<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03769896</url>
  </required_header>
  <id_info>
    <org_study_id>1.4</org_study_id>
    <nct_id>NCT03769896</nct_id>
  </id_info>
  <brief_title>Nabilone for Non-motor Symptoms in Parkinson's Disease</brief_title>
  <acronym>NMS-Nab</acronym>
  <official_title>Nabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment&#xD;
      randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor&#xD;
      symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of&#xD;
      tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a&#xD;
      partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and&#xD;
      therefore mimics the effect of THC but with more predictable side effects and less euphoria.&#xD;
&#xD;
      Part 1 is an open-label dose adjustment phase of the study. In eligible patients, a screening&#xD;
      period is followed by an open-label nabilone dose optimization phase and a stable phase for&#xD;
      at least 1 week. Treatment responders will be included in Part 2 of the study (randomized&#xD;
      placebo-controlled, double-blind, parallel-grouped).&#xD;
&#xD;
      Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of&#xD;
      the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment&#xD;
      randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor&#xD;
      symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of&#xD;
      tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a&#xD;
      partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and&#xD;
      therefore mimics the effect of THC but with more predictable side effects and less euphoria.&#xD;
&#xD;
      Part 1 is the open-label dose adjustment phase of the study. In Part 1, eligible subjects,&#xD;
      who have signed the informed consent form at the screening visit, will receive open-label&#xD;
      nabilone starting with a dosage of 0.25 mg in the evening. During dose titration and&#xD;
      optimization, nabilone will be titrated in 0.25 mg increments (increase by 0.25 mg/ every one&#xD;
      to four days) up to a maximum dose of 1 mg twice daily. Patients should be on a stable&#xD;
      nabilone dose for at least 1 week afterwards until Baseline Visit (V 0).&#xD;
&#xD;
      Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of&#xD;
      the study. At Baseline Visit, treatment responders will be included in Part 2 of the study&#xD;
      (randomized placebo-controlled, double-blind, parallel-grouped). Responders are randomized in&#xD;
      a 1:1 ratio at Baseline Visit to receive either nabilone or matching placebo for 4 weeks + 2&#xD;
      days. The placebo-controlled, double-blind, randomized withdrawal phase will end with a&#xD;
      clinic visit (Termination Visit V 1). Following this, the study medication will be tapered in&#xD;
      all patients. During this period the patients will receive phone calls every other day. A&#xD;
      Safety Telephone Call and a Safety Follow-Up Visit will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">July 15, 2019</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>placebo-controlled, double-blind, parallel-group with 1 : 1 randomization</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Non-motor Symptoms</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Motor and Different Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part II: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.&#xD;
Part III: minimum points: 0, maximum points: 132, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Different Domains of Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4) and different other domains of NMSS and MDS-UPDRS part I Each items scores 0 to 4 points with higher score values indicating a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Non-motor Symptoms of PD</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Global Improvement (CGI-I) Scale</measure>
    <time_frame>Values of the Termination visit (4 weeks + 2 days from baseline)</time_frame>
    <description>Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Safety and tolerability will be evaluated with reference to the following:&#xD;
Number of subjects (%) who discontinue the study Number of subjects (%) who discontinue the study due to AE Adverse Events (AE): total number of patients with all adverse events is reported (no reporting threshold)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicidality in PD Patients Taking Nabilone.</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Assessment of aggregated data (suicidality present / no suicidality) of the Columbia-Suicide Severity Rating Scale (C-SSRS). The scale consists of questions for suicidality that can be answered with either &quot;yes&quot; or &quot;no&quot;. The answer &quot;no&quot; indicates no wish to be dead, no suicidal ideations, or suicidal attempts.&#xD;
No minimum or maximum score values can be provided. The values provided represent the number of patients with (new) suicidality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hallucinations in PD Patients Taking Nabilone</measure>
    <time_frame>from baseline to 4 weeks + 2 days</time_frame>
    <description>Number of patients with changes in the points of the Hallucination item (1.2) of the Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orthostatic Hypotension in PD Patients Taking Nabilone</measure>
    <time_frame>from baseline to week 4 + 2 days</time_frame>
    <description>Changes in points of the Orthostatic hypotension (OH) item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS), minimum of 0, maximum of 4 points, higher score values representing a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS</measure>
    <time_frame>from baseline to week 4 + 2 days</time_frame>
    <description>Changes in points of the Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) , minimum of 0, maximum of 4 points, higher score values representing a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Incompliance in PD Patients Taking Nabilone</measure>
    <time_frame>from baseline to week 4 + 2 days</time_frame>
    <description>subject incompliance as per drug accountability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight (kg) in PD Patients Taking Nabilone.</measure>
    <time_frame>from baseline to week 4 + 2 days</time_frame>
    <description>changes in weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.</measure>
    <time_frame>from baseline to week 4 + 2 days</time_frame>
    <description>changes in temperature (degree Celsius)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.</measure>
    <time_frame>values from baseline and week 4 + 2 days</time_frame>
    <description>changes in supine and standing blood pressure measurements (mmHg)&#xD;
Row titles:&#xD;
Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the baseline visit&#xD;
Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit&#xD;
Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit&#xD;
Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life of PD</measure>
    <time_frame>from baseline to week 4 + 2 days</time_frame>
    <description>Parkinson´s Disease Questionnaire - 39 (PDQ-39) Minimum: 0, maximum: 156, higher score values indicate a worse outcome. Values were standardized = PDQ-39 Summary Index (SI, the score of each subdomain was divided by the number of questions of that domain and then multiplied by hundred, the sum score is the sum of the results of all 8 domains)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo.</measure>
    <time_frame>Maximum of 104 days</time_frame>
    <description>Change of the reaction time (seconds) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo.</measure>
    <time_frame>Maximum of 104 days</time_frame>
    <description>Change of attention span and ability to concentrate (error rate, correct trials) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nabilone 0.25 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (corn starch)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nabilone 0.25 mg</intervention_name>
    <description>capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>capsule, corn starch, daily basis</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        In order to be eligible for the study subjects must meet all inclusion criteria:&#xD;
&#xD;
          1. Age ≥30 years&#xD;
&#xD;
          2. Diagnosis of Parkinson´s Disease (PD): PD should be either de novo or on stable&#xD;
             medication without disturbing motor fluctuations or dyskinesia.&#xD;
&#xD;
          3. NMS with a score of ≥4 on MDS-UPDRS Part 1. One of the following domains have to be&#xD;
             affected with a score ≥2: 1.4 (anxious mood) or 1.9 (pain)&#xD;
&#xD;
          4. On a stable regimen of anti-parkinson medications for at least 30 days prior to&#xD;
             screening and willing to continue the same doses and regimens during study&#xD;
             participation&#xD;
&#xD;
          5. Any other current and allowed prescription/non-prescription medications and/or&#xD;
             nutritional supplements taken regularly must have been at a stable dose and regimen&#xD;
             for at least 30 days prior to screening, and subject must be willing to continue the&#xD;
             same doses and regimens during study participation&#xD;
&#xD;
          6. Patient is informed and had enough time and opportunity to think about his/her&#xD;
             participation in the study and has signed a current Institutional Review&#xD;
             Board-approved informed consent form&#xD;
&#xD;
          7. Contraception&#xD;
&#xD;
               1. Women of childbearing potential must use or attest an acceptable method* of&#xD;
                  contraception starting 4 weeks prior to study drug administration and for a&#xD;
                  minimum of 1 month after study completion.&#xD;
&#xD;
               2. Men with a potentially fertile partner must be willing to use an acceptable&#xD;
                  method of contraception for the duration of the study and for 3 months after&#xD;
                  study drug discontinuation or have had a vasectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with any of the following characteristics will be excluded from entering the&#xD;
        study:&#xD;
&#xD;
          1. Patient previously participated in any study with nabilone.&#xD;
&#xD;
          2. Current use of cannabinoids or use of cannabinoids within 30 days prior to screening.&#xD;
&#xD;
          3. Patient is currently participating in or has participated in another study of&#xD;
             investigational products within 30 days prior to screening.&#xD;
&#xD;
          4. Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post&#xD;
             stroke).&#xD;
&#xD;
          5. Patient presents with motor complications which are, based on the investigator's&#xD;
             judgment, not adequately controlled (i.e. a score ≥2 on one of the items of the&#xD;
             MDS-UPDRS Part IV at screening)&#xD;
&#xD;
          6. Hoehn and Yahr stage &gt; 3&#xD;
&#xD;
          7. Evidence of disturbing (i.e. requiring treatment) impulse control disorder in the&#xD;
             participant. Can be resolved through a structural interview during screening period.&#xD;
&#xD;
          8. History of neurosurgical intervention for PD&#xD;
&#xD;
          9. presence of symptomatic orthostatic hypotension at screening (MDS-UPDRS 1.12 &gt; 2)&#xD;
&#xD;
         10. Use of prohibited medication (e.g. benzodiazepines (except for clonazepam up to a&#xD;
             maximum of 1.5 mg per d), lithium, opioids, buspirone, muscle relaxing agents, central&#xD;
             nervous system depressing substances, ...)&#xD;
&#xD;
         11. Patients with laboratory values that are out-of-range at Screening (or within 4 weeks&#xD;
             prior to Screening) and haven´t been reviewed and documented as not clinically&#xD;
             significant by the investigator. Lab Tests can be repeated for confirmation.&#xD;
&#xD;
         12. Patients with known or newly diagnosed sinus tachycardia in ECG evaluation at&#xD;
             Screening or within 4 weeks prior to Screening.&#xD;
&#xD;
         13. presence of an acute or chronic major psychiatric disorder (e.g., Major Depressive&#xD;
             Disorder, psychosis) or symptom (e.g., hallucinations, agitation, paranoia) (MDS-UPDRS&#xD;
             1.2 and/or 1.3 &gt; 2)&#xD;
&#xD;
         14. Patients who had a recent suicidal attempt (active, interrupted, aborted) within the&#xD;
             past five years or report suicidal ideation within the past 6 months.&#xD;
&#xD;
         15. presence of dementia (MDS-UPDRS 1.1 &gt; 2, Mini-Mental State Examination of &lt;24 at the&#xD;
             Screening visit)&#xD;
&#xD;
         16. clinically significant or unstable medical or surgical condition at Screening or&#xD;
             Baseline visit that may preclude safety and the completion of the study participation&#xD;
             (based on the investigator's judgment).&#xD;
&#xD;
         17. Patients with moderate or severe hepatic or renal impairment.&#xD;
&#xD;
         18. Patient has a history of chronic alcohol or drug abuse within the last 2 years.&#xD;
&#xD;
         19. women of child-bearing potential who do not practice an acceptable method of birth&#xD;
             control&#xD;
&#xD;
         20. Pregnant women or women planning to become pregnant during the course of the study and&#xD;
             nursing women.&#xD;
&#xD;
         21. Patients who are knowingly hypersensitive to any of the components of the&#xD;
             investigational medicinal product or excipients.&#xD;
&#xD;
         22. Patient is legally incapacitated or persons held in an institution by legal or&#xD;
             official order&#xD;
&#xD;
         23. Persons with any kind of dependency on the investigator or employed by the Sponsor or&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neurology - Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <results_first_submitted>August 22, 2020</results_first_submitted>
  <results_first_submitted_qc>February 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 2, 2021</results_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University Innsbruck</investigator_affiliation>
    <investigator_full_name>Klaus Seppi, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Parkinson´s Disease</keyword>
  <keyword>cannabinoids</keyword>
  <keyword>non-motor symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nabilone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The results of this study will be published according to the principles of publication policy. There are no arrangements on publication issues with subsiding parties.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03769896/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>location: Medical Clinic, period: October 2017 to July 2019</recruitment_details>
      <pre_assignment_details>Phase 1: open-label nabilone titration (0.25mg - 2mg). Phase 2: double-blind phase There was one screening failure due to the use of prohibited concomitant medication.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment Group</title>
          <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
        </group>
        <group group_id="P2">
          <title>Placebo Group</title>
          <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Open-label Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Double-blind Treatment Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>baseline characteristics (as assessed at the screening visit) for the 38 randomized patients</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Group</title>
          <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
        </group>
        <group group_id="B2">
          <title>Placebo Group</title>
          <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.38" spread="7.94"/>
                    <measurement group_id="B2" value="63.95" spread="8.04"/>
                    <measurement group_id="B3" value="65.05" spread="8.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="00"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.83" spread="5.47"/>
                    <measurement group_id="B2" value="7.39" spread="5.14"/>
                    <measurement group_id="B3" value="7.61" spread="5.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hoehn and Yahr Scale</title>
          <description>Hoehn and Yahr scale:&#xD;
is used to assess the severity / disease stage of Parkinson´s disease patients&#xD;
5-point Likert scale&#xD;
the total score ranges from a minimum of 0 to a maximum of 5&#xD;
higher values indicate worse status&#xD;
The total score values are reported in this table.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.84" spread="0.50"/>
                    <measurement group_id="B2" value="1.95" spread="0.41"/>
                    <measurement group_id="B3" value="1.89" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MDS-UPDRS Total Score</title>
          <description>Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS)&#xD;
Total score reported is the sum of Parts I to IV.&#xD;
Part I minimum points: 0, maximum points: 52, Part II: minimum points: 0, maximum points: 52, Part III: minimum points: 0, maximum points: 132, Part IV: minimum points: 0, maximum points: 24.&#xD;
Total MDS-UPDRS score: minimum: 0, maximum: 260.&#xD;
Higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.05" spread="22.97"/>
                    <measurement group_id="B2" value="52.05" spread="14.75"/>
                    <measurement group_id="B3" value="52.05" spread="19.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MDS-UPDRS-I</title>
          <description>Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I&#xD;
minimum points: 0, maximum points: 52.&#xD;
higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.53" spread="4.39"/>
                    <measurement group_id="B2" value="12.26" spread="5.85"/>
                    <measurement group_id="B3" value="12.89" spread="5.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes of Non-motor Symptoms</title>
        <description>Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes of Non-motor Symptoms</title>
          <description>Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="-0.16" upper_limit="2.16"/>
                    <measurement group_id="O2" value="2.63" lower_limit="1.53" upper_limit="3.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Motor and Different Non-motor Symptoms of PD</title>
        <description>Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part II: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.&#xD;
Part III: minimum points: 0, maximum points: 132, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Motor and Different Non-motor Symptoms of PD</title>
          <description>Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part II: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.&#xD;
Part III: minimum points: 0, maximum points: 132, higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MDS-UPDRS II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" lower_limit="-0.37" upper_limit="1.31"/>
                    <measurement group_id="O2" value="0.90" lower_limit="-0.35" upper_limit="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MDS-UPDRS III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" lower_limit="-2.24" upper_limit="3.29"/>
                    <measurement group_id="O2" value="2.63" lower_limit="0.25" upper_limit="5.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Different Domains of Non-motor Symptoms of PD</title>
        <description>mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4) and different other domains of NMSS and MDS-UPDRS part I Each items scores 0 to 4 points with higher score values indicating a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Different Domains of Non-motor Symptoms of PD</title>
          <description>mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4) and different other domains of NMSS and MDS-UPDRS part I Each items scores 0 to 4 points with higher score values indicating a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MDS-UPDRS 1.3 Depressed Mood</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" lower_limit="-0.17" upper_limit="0.38"/>
                    <measurement group_id="O2" value="0.16" lower_limit="-0.08" upper_limit="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MDS-UPDRS 1.4 Anxious Mood</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" lower_limit="-0.53" upper_limit="0.21"/>
                    <measurement group_id="O2" value="0.21" lower_limit="-0.05" upper_limit="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MDS-UPDRS 1.7 Nighttime sleep problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" lower_limit="-0.47" upper_limit="0.57"/>
                    <measurement group_id="O2" value="1.79" lower_limit="1.15" upper_limit="2.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Non-motor Symptoms of PD</title>
        <description>Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Non-motor Symptoms of PD</title>
          <description>Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.05" lower_limit="-0.65" upper_limit="8.75"/>
                    <measurement group_id="O2" value="11.00" lower_limit="4.68" upper_limit="17.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Non-motor Symptoms of PD</title>
        <description>Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Non-motor Symptoms of PD</title>
          <description>Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hospital anxiety and depression scale - Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="-0.87" upper_limit="1.40"/>
                    <measurement group_id="O2" value="0.05" lower_limit="-1.09" upper_limit="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospital anxiety and depression scale - Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" lower_limit="-1.11" upper_limit="1.74"/>
                    <measurement group_id="O2" value="0.16" lower_limit="-0.71" upper_limit="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Non-motor Symptoms of PD</title>
        <description>Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Non-motor Symptoms of PD</title>
          <description>Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.74" lower_limit="-1.87" upper_limit="0.40"/>
                    <measurement group_id="O2" value="-0.79" lower_limit="-1.85" upper_limit="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Non-motor Symptoms of PD</title>
        <description>Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Non-motor Symptoms of PD</title>
          <description>Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.00" lower_limit="-9.77" upper_limit="1.77"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-5.26" upper_limit="5.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Non-motor Symptoms of PD</title>
        <description>King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Non-motor Symptoms of PD</title>
          <description>King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.58" lower_limit="-2.73" upper_limit="5.89"/>
                    <measurement group_id="O2" value="2.84" lower_limit="-5.19" upper_limit="10.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Non-motor Symptoms of PD</title>
        <description>Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Non-motor Symptoms of PD</title>
          <description>Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.68" lower_limit="-1.49" upper_limit="0.12"/>
                    <measurement group_id="O2" value="0.05" lower_limit="-0.64" upper_limit="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Non-motor Symptoms of PD</title>
        <description>Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Non-motor Symptoms of PD</title>
          <description>Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" lower_limit="-0.18" upper_limit="1.66"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-0.63" upper_limit="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Non-motor Symptoms of PD</title>
        <description>Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Non-motor Symptoms of PD</title>
          <description>Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome.</description>
          <units>millimeters on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.58" lower_limit="-5.65" upper_limit="18.81"/>
                    <measurement group_id="O2" value="2.16" lower_limit="-8.40" upper_limit="12.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression - Global Improvement (CGI-I) Scale</title>
        <description>Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome.</description>
        <time_frame>Values of the Termination visit (4 weeks + 2 days from baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression - Global Improvement (CGI-I) Scale</title>
          <description>Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.95" spread="0.71"/>
                    <measurement group_id="O2" value="4.42" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.</title>
        <description>Safety and tolerability will be evaluated with reference to the following:&#xD;
Number of subjects (%) who discontinue the study Number of subjects (%) who discontinue the study due to AE Adverse Events (AE): total number of patients with all adverse events is reported (no reporting threshold)</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.</title>
          <description>Safety and tolerability will be evaluated with reference to the following:&#xD;
Number of subjects (%) who discontinue the study Number of subjects (%) who discontinue the study due to AE Adverse Events (AE): total number of patients with all adverse events is reported (no reporting threshold)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of subjects who discontinue the study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects who discontinue due to AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total number of patients with Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Suicidality in PD Patients Taking Nabilone.</title>
        <description>Assessment of aggregated data (suicidality present / no suicidality) of the Columbia-Suicide Severity Rating Scale (C-SSRS). The scale consists of questions for suicidality that can be answered with either &quot;yes&quot; or &quot;no&quot;. The answer &quot;no&quot; indicates no wish to be dead, no suicidal ideations, or suicidal attempts.&#xD;
No minimum or maximum score values can be provided. The values provided represent the number of patients with (new) suicidality.</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Suicidality in PD Patients Taking Nabilone.</title>
          <description>Assessment of aggregated data (suicidality present / no suicidality) of the Columbia-Suicide Severity Rating Scale (C-SSRS). The scale consists of questions for suicidality that can be answered with either &quot;yes&quot; or &quot;no&quot;. The answer &quot;no&quot; indicates no wish to be dead, no suicidal ideations, or suicidal attempts.&#xD;
No minimum or maximum score values can be provided. The values provided represent the number of patients with (new) suicidality.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hallucinations in PD Patients Taking Nabilone</title>
        <description>Number of patients with changes in the points of the Hallucination item (1.2) of the Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).</description>
        <time_frame>from baseline to 4 weeks + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hallucinations in PD Patients Taking Nabilone</title>
          <description>Number of patients with changes in the points of the Hallucination item (1.2) of the Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Orthostatic Hypotension in PD Patients Taking Nabilone</title>
        <description>Changes in points of the Orthostatic hypotension (OH) item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS), minimum of 0, maximum of 4 points, higher score values representing a worse outcome.</description>
        <time_frame>from baseline to week 4 + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Orthostatic Hypotension in PD Patients Taking Nabilone</title>
          <description>Changes in points of the Orthostatic hypotension (OH) item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS), minimum of 0, maximum of 4 points, higher score values representing a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" lower_limit="-0.13" upper_limit="0.55"/>
                    <measurement group_id="O2" value="-0.26" lower_limit="-0.65" upper_limit="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS</title>
        <description>Changes in points of the Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) , minimum of 0, maximum of 4 points, higher score values representing a worse outcome</description>
        <time_frame>from baseline to week 4 + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS</title>
          <description>Changes in points of the Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) , minimum of 0, maximum of 4 points, higher score values representing a worse outcome</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="-0.01" upper_limit="0.53"/>
                    <measurement group_id="O2" value="0.11" lower_limit="-0.21" upper_limit="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Incompliance in PD Patients Taking Nabilone</title>
        <description>subject incompliance as per drug accountability.</description>
        <time_frame>from baseline to week 4 + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Incompliance in PD Patients Taking Nabilone</title>
          <description>subject incompliance as per drug accountability.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight (kg) in PD Patients Taking Nabilone.</title>
        <description>changes in weight (kg)</description>
        <time_frame>from baseline to week 4 + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Weight (kg) in PD Patients Taking Nabilone.</title>
          <description>changes in weight (kg)</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="2.33"/>
                    <measurement group_id="O2" value="-0.52" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.</title>
        <description>changes in temperature (degree Celsius)</description>
        <time_frame>from baseline to week 4 + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.</title>
          <description>changes in temperature (degree Celsius)</description>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.56"/>
                    <measurement group_id="O2" value="0.35" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.</title>
        <description>changes in supine and standing blood pressure measurements (mmHg)&#xD;
Row titles:&#xD;
Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the baseline visit&#xD;
Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit&#xD;
Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit&#xD;
Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit</description>
        <time_frame>values from baseline and week 4 + 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.</title>
          <description>changes in supine and standing blood pressure measurements (mmHg)&#xD;
Row titles:&#xD;
Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the baseline visit&#xD;
Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit&#xD;
Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit&#xD;
Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Change supine - 3 min standing, SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.47" spread="13.88"/>
                    <measurement group_id="O2" value="-4.05" spread="11.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week4: Change supine - 3 min standing, SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.84" spread="10.68"/>
                    <measurement group_id="O2" value="-2.95" spread="17.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Change supine - 3 min standing, DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.79" spread="5.84"/>
                    <measurement group_id="O2" value="3.16" spread="6.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week4: Change supine - 3 min standing, DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="5.95"/>
                    <measurement group_id="O2" value="-0.79" spread="7.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Quality of Life of PD</title>
        <description>Parkinson´s Disease Questionnaire - 39 (PDQ-39) Minimum: 0, maximum: 156, higher score values indicate a worse outcome. Values were standardized = PDQ-39 Summary Index (SI, the score of each subdomain was divided by the number of questions of that domain and then multiplied by hundred, the sum score is the sum of the results of all 8 domains)</description>
        <time_frame>from baseline to week 4 + 2 days</time_frame>
        <population>PDQ-39 SI values reported</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Quality of Life of PD</title>
          <description>Parkinson´s Disease Questionnaire - 39 (PDQ-39) Minimum: 0, maximum: 156, higher score values indicate a worse outcome. Values were standardized = PDQ-39 Summary Index (SI, the score of each subdomain was divided by the number of questions of that domain and then multiplied by hundred, the sum score is the sum of the results of all 8 domains)</description>
          <population>PDQ-39 SI values reported</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" lower_limit="-3.04" upper_limit="2.05"/>
                    <measurement group_id="O2" value="-0.47" lower_limit="-3.21" upper_limit="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo.</title>
        <description>Change of the reaction time (seconds) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.</description>
        <time_frame>Maximum of 104 days</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo.</title>
        <description>Change of attention span and ability to concentrate (error rate, correct trials) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.</description>
        <time_frame>Maximum of 104 days</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Each patient was assessed from first intake of study drug to study discontinuation.</time_frame>
      <desc>definitions do not differ</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group (Open-label Phase)</title>
          <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
        </group>
        <group group_id="E2">
          <title>Treatment Group (Double-blind Phase)</title>
          <description>Nabilone 0.25 mg&#xD;
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis</description>
        </group>
        <group group_id="E3">
          <title>Placebo Group (Double-blind Phase)</title>
          <description>Placebo (corn starch)&#xD;
Placebo: capsule, corn starch, daily basis</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain (including worsening)</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fall (including recurrent falls)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Daytime sleepiness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>negative expectations might impact results (due to withdrawal design), sample size of 38 patients (double-blind phase), all caucasian patients</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Prof. Klaus Seppi</name_or_title>
      <organization>Medical University of Innsbruck</organization>
      <phone>004351250481553</phone>
      <email>klaus.seppi@tirol-kliniken.at</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03769896
org study id: 1.4
nct id: NCT03769896
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment
      randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor
      symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of
      tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a
      partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and
      therefore mimics the effect of THC but with more predictable side effects and less euphoria.

      Part 1 is an open-label dose adjustment phase of the study. In eligible patients, a screening
      period is followed by an open-label nabilone dose optimization phase and a stable phase for
      at least 1 week. Treatment responders will be included in Part 2 of the study (randomized
      placebo-controlled, double-blind, parallel-grouped).

      Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of
      the study.
This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment
      randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor
      symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of
      tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a
      partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and
      therefore mimics the effect of THC but with more predictable side effects and less euphoria.

      Part 1 is the open-label dose adjustment phase of the study. In Part 1, eligible subjects,
      who have signed the informed consent form at the screening visit, will receive open-label
      nabilone starting with a dosage of 0.25 mg in the evening. During dose titration and
      optimization, nabilone will be titrated in 0.25 mg increments (increase by 0.25 mg/ every one
      to four days) up to a maximum dose of 1 mg twice daily. Patients should be on a stable
      nabilone dose for at least 1 week afterwards until Baseline Visit (V 0).

      Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of
      the study. At Baseline Visit, treatment responders will be included in Part 2 of the study
      (randomized placebo-controlled, double-blind, parallel-grouped). Responders are randomized in
      a 1:1 ratio at Baseline Visit to receive either nabilone or matching placebo for 4 weeks + 2
      days. The placebo-controlled, double-blind, randomized withdrawal phase will end with a
      clinic visit (Termination Visit V 1). Following this, the study medication will be tapered in
      all patients. During this period the patients will receive phone calls every other day. A
      Safety Telephone Call and a Safety Follow-Up Visit will be performed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: placebo-controlled, double-blind, parallel-group with 1 : 1 randomization
measure: Changes of Non-motor Symptoms
time frame: from baseline to 4 weeks + 2 days
description: Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.
measure: Changes in Motor and Different Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part II: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.
Part III: minimum points: 0, maximum points: 132, higher score values indicate a worse outcome.
measure: Changes in Different Domains of Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4) and different other domains of NMSS and MDS-UPDRS part I Each items scores 0 to 4 points with higher score values indicating a worse outcome.
measure: Changes in Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.
measure: Changes in Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome.
measure: Changes in Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.
measure: Changes in Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome.
measure: Changes in Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.
measure: Changes in Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome.
measure: Changes in Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome.
measure: Changes in Non-motor Symptoms of PD
time frame: from baseline to 4 weeks + 2 days
description: Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome.
measure: Clinical Global Impression - Global Improvement (CGI-I) Scale
time frame: Values of the Termination visit (4 weeks + 2 days from baseline)
description: Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome.
measure: Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.
time frame: from baseline to 4 weeks + 2 days
description: Safety and tolerability will be evaluated with reference to the following:
Number of subjects (%) who discontinue the study Number of subjects (%) who discontinue the study due to AE Adverse Events (AE): total number of patients with all adverse events is reported (no reporting threshold)
measure: Suicidality in PD Patients Taking Nabilone.
time frame: from baseline to 4 weeks + 2 days
description: Assessment of aggregated data (suicidality present / no suicidality) of the Columbia-Suicide Severity Rating Scale (C-SSRS). The scale consists of questions for suicidality that can be answered with either "yes" or "no". The answer "no" indicates no wish to be dead, no suicidal ideations, or suicidal attempts.
No minimum or maximum score values can be provided. The values provided represent the number of patients with (new) suicidality.
measure: Change in Hallucinations in PD Patients Taking Nabilone
time frame: from baseline to 4 weeks + 2 days
description: Number of patients with changes in the points of the Hallucination item (1.2) of the Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).
measure: Orthostatic Hypotension in PD Patients Taking Nabilone
time frame: from baseline to week 4 + 2 days
description: Changes in points of the Orthostatic hypotension (OH) item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS), minimum of 0, maximum of 4 points, higher score values representing a worse outcome.
measure: Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS
time frame: from baseline to week 4 + 2 days
description: Changes in points of the Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) , minimum of 0, maximum of 4 points, higher score values representing a worse outcome
measure: Subject Incompliance in PD Patients Taking Nabilone
time frame: from baseline to week 4 + 2 days
description: subject incompliance as per drug accountability.
measure: Weight (kg) in PD Patients Taking Nabilone.
time frame: from baseline to week 4 + 2 days
description: changes in weight (kg)
measure: Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.
time frame: from baseline to week 4 + 2 days
description: changes in temperature (degree Celsius)
measure: Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.
time frame: values from baseline and week 4 + 2 days
description: changes in supine and standing blood pressure measurements (mmHg)
Row titles:
Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the baseline visit
Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit
Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit
Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit
measure: Changes in Quality of Life of PD
time frame: from baseline to week 4 + 2 days
description: Parkinson´s Disease Questionnaire - 39 (PDQ-39) Minimum: 0, maximum: 156, higher score values indicate a worse outcome. Values were standardized = PDQ-39 Summary Index (SI, the score of each subdomain was divided by the number of questions of that domain and then multiplied by hundred, the sum score is the sum of the results of all 8 domains)
measure: The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo.
time frame: Maximum of 104 days
description: Change of the reaction time (seconds) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.
measure: The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo.
time frame: Maximum of 104 days
description: Change of attention span and ability to concentrate (error rate, correct trials) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.
arm group label: Treatment Group
arm group type: Active Comparator
description: Nabilone 0.25 mg
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Placebo (corn starch)
intervention type: Drug
intervention name: Nabilone 0.25 mg
description: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
arm group label: Treatment Group
intervention type: Drug
intervention name: Placebo
description: capsule, corn starch, daily basis
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University Innsbruck
investigator full name: Klaus Seppi, MD
investigator title: Principal Investigator
mesh term: Parkinson Disease
mesh term: Nabilone
sharing ipd: No
ipd description: The results of this study will be published according to the principles of publication policy. There are no arrangements on publication issues with subsiding parties.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: negative expectations might impact results (due to withdrawal design), sample size of 38 patients (double-blind phase), all caucasian patients
point of contact: 