<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/NCT03808935</url>
  </required_header>
  <id_info>
    <org_study_id>EPL29</org_study_id>
    <nct_id>NCT03808935</nct_id>
  </id_info>
  <brief_title>Cannabis Extract in Refractory Epilepsy Study</brief_title>
  <acronym>CERES</acronym>
  <official_title>A Double-Blind, Placebo-Controlled, Parallel-Group Study of Cannabidiol Plus Tetrahydrocannabinol (CBD+THC) Given as Adjunctive Therapy in Patients With Refractory Seizures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Epilepsy Research Program of the Ontario Brain Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Brain Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MedReleaf</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Epilepsy Research Program of the Ontario Brain Institute</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>
      The purpose of this study is to examine whether a low dose of CBD+THC will decrease the&#xD;
      frequency of convulsive seizures in adults with drug-resistant epilepsy, when used in&#xD;
      addition to standard anti-epileptic drugs (AEDs). This study will also study the genes&#xD;
      associated with epilepsy and whether different epileptic syndromes respond to treatment with&#xD;
      CBD+THC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) are the two major compounds&#xD;
      found in the cannabis plant. Reports from patients, families, and the scientific community&#xD;
      suggest that CBD (when used as an add-on therapy) decreases the number of convulsive seizures&#xD;
      in children and adults with Dravet syndrome, Lennox-Gastaut syndrome, and Tuberous sclerosis&#xD;
      complex.&#xD;
&#xD;
      Trial design: Phase III, double-blind, randomized, placebo-controlled, parallel-group trial,&#xD;
      followed by an open phase where treatment allocation will be revealed and all participants&#xD;
      will either continue or begin receiving the active study drug.&#xD;
&#xD;
      Participants: Adults (18 years of age and older) with drug-resistant epilepsy, including&#xD;
      patients with Dravet and Lennox Gastaut syndromes, and patients with frequent convulsive&#xD;
      seizures (e.g., tonic, tonic-clonic, atonic, drop attacks, and focal motor seizures).&#xD;
&#xD;
      Interventions: Capsules containing a ratio of 16 CBD: 1 THC oil at a maximum total daily dose&#xD;
      of approximately 300 mg of CBD per day, divided into equal doses in the morning and evening.&#xD;
&#xD;
      Comparator: Placebo capsules containing high-oleic sunflower oil and no active or medicinal&#xD;
      ingredients.&#xD;
&#xD;
      Outcomes: Frequency of seizures; side effects; blood levels of AEDs, CBD, THC, and liver&#xD;
      enzymes; impact on cognition and quality of life; genetics.&#xD;
&#xD;
      Sample size: A total of 80 participants (40 assigned to treatment and 40 to control group)&#xD;
      recruited from Toronto Western Hospital in Toronto, and University Hospital in London,&#xD;
      Ontario.&#xD;
&#xD;
      Time: Each participant will be enrolled for approximately 16 to 18 weeks, while the clinical&#xD;
      trial is expected to take place over a period of two years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Participants are no longer being examined or receiving intervention.&#xD;
  </why_stopped>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of convulsive seizures</measure>
    <time_frame>0 - 10 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by the adverse events questionnaire</measure>
    <time_frame>0- 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood levels of CBD and THC from baseline to end of treatment</measure>
    <time_frame>0 - 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood levels of AEDs from baseline to end of treatment</measure>
    <time_frame>0 - 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood levels of liver enzymes AST, ALT, and GGT from baseline to end of treatment</measure>
    <time_frame>0 - 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life from baseline to end of treatment as assessed by the Quality of Life in Epilepsy Inventory (QOLIE-31) questionnaire</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>QOLIE-31 is a 31-item measure assessing health-related quality of life in adults with epilepsy. Seven scales assess seizure worry, overall quality of life, emotional well-being, cognitive and medication effects, and social function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life from baseline to end of treatment as assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>WHOQOL-BREF is a 26-item measure of physical health, psychological health, social relationships, and environment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life from baseline to end of treatment as assessed by the Quality of Life Childhood Epilepsy (QOLCE) questionnaire</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>QOLCE is a 55-item scale assessing health-related quality of life in children with epilepsy from the perspective of the parent or caregiver. It covers cognitive, emotional, social, and physical functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in symptoms of depression from baseline to end of treatment as assessed by the Neurological Disorder Depression Inventory for Epilepsy (NDDI-E)</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>NDDI-E is a 6-item questionnaire designed to screen for depression in adults with epilepsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in symptoms of depression from baseline to end of treatment as assessed by the Quick Inventory of Depressive Symptoms (QIDS)</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>QIDS is a 16-item measure designed to assess the severity of depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in symptoms of anxiety from baseline to end of treatment as assessed by the Generalized Anxiety Disorder 7-item (GAD-7)</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>GAD-7 is a 7-item questionnaire assessing severity of generalized anxiety disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overall severity of epilepsy from baseline to end of treatment as assessed by the Global Analysis of Severity of Epilepsy Scale (GASE)</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>GASE is a single-item, 7-point global rating scale that was designed to assess the overall severity of epilepsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of sleep from baseline to end of treatment as assessed by the Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>PSQI is a 19-item measure assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in participant's impression of change from baseline to end of treatment as assessed by the Patients' Global Impression of Change (PGIC) scale</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>PGIC is a 7-point scale assessing the patient's perspective of overall improvement and efficacy of treatment. Scores range from &quot;very much improved&quot; to &quot;very much worse&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in caregiver's impression of change from baseline to end of treatment as assessed by the Caregiver's Global Impression of Change (CGIC) scale</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>CGIC is a 7-point scale assessing the caregiver's perspective of overall improvement and efficacy of treatment. Scores range from &quot;very much improved&quot; to &quot;very much worse&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychological symptoms from baseline to end of treatment as assessed by the Brief Symptom Inventory (BSI-53)</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>BSI-53 is a 53-item measure assessing psychological profiles. It covers 9 primary domains: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional impairment from baseline to end of treatment as assessed by the Sheehan Disability Scale (SDS)</measure>
    <time_frame>0 - 10 weeks</time_frame>
    <description>SDS is a 5-item measure assessing functional impairment in three inter-related domains: work/school, social, and family life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Drug Resistant Epilepsy</condition>
  <arm_group>
    <arm_group_label>Medical cannabis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules containing cannabis extract, dissolved in high-oleic sunflower oil, and CBD/THC in a 16:1 ratio.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsules containing a high-oleic sunflower oil, calorie-equated to the active treatment. There will be no active compounds in the placebo treatment.&#xD;
Following treatment with placebo, all participants in this group will begin treatment with medical cannabis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medical Cannabis</intervention_name>
    <description>The experimental intervention will begin with two weeks of titration (100 mg to 200 mg of CBD per day), followed by four weeks of treatment (maximum 300 mg of CBD per day) and four weeks of maintenance (maximum 300 mg of CBD per day). A two week washout phase will slowly decrease the daily dose (200 mg to 100 mg of CBD per day). All daily doses are equally divided into a morning and evening dose.</description>
    <arm_group_label>Medical cannabis</arm_group_label>
    <other_name>CBD/THC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The placebo intervention will begin with two weeks of titration, followed by four weeks of treatment. Participants will then be unblinded to their study group and begin two weeks of titration, four weeks of treatment, and two weeks of washout with medical cannabis, following the same dosing and schedule as the experimental group. All daily doses are equally divided into a morning and evening dose.</description>
    <arm_group_label>Placebo Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of epilepsy according to the ILAE classification.&#xD;
&#xD;
          -  At least 4 motor seizures per month at the start of the study, despite treatment with&#xD;
             at least two different anti-epileptic drugs (given concurrently or sequentially) for&#xD;
             at least one year.&#xD;
&#xD;
          -  At least 4 motor seizures per month during the prospective baseline phase (4 weeks)&#xD;
             with no 21-day seizure free periods.&#xD;
&#xD;
          -  Stable dose(s) of the same AED(s) for one month prior to screening.&#xD;
&#xD;
          -  Agrees not to take any cannabinoids during the study or any other investigational&#xD;
             compound for one month before the study or outside cannabinoids during the study.&#xD;
&#xD;
          -  Is planning to stay in Canada for the duration of the trial.&#xD;
&#xD;
          -  Is able to travel to one of the study sites for in-person visits with the study&#xD;
             physicians and to a local lab for blood collection.&#xD;
&#xD;
          -  Has access to telephone, computer, and internet for regular correspondence and to&#xD;
             complete the study questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a study involving administration of an investigational compound&#xD;
             within one month of Visit 1.&#xD;
&#xD;
          -  Evidence of clinically significant non-epileptic disease (cardiac, respiratory,&#xD;
             gastrointestinal, hepatic, hematologic, or renal disease, etc.) that in the opinion of&#xD;
             the investigators could affect the patient's safety or trial conduct.&#xD;
&#xD;
          -  Progressive central nervous system (CNS) disease, including degenerative CNS diseases&#xD;
             and progressive tumors.&#xD;
&#xD;
          -  Occurrence of psychogenic seizures in the previous year.&#xD;
&#xD;
          -  History of drug misuse/abuse (other than cannabinoids). Consideration may be given to&#xD;
             allowing inclusion of subjects with remote history of drug abuse (within a defined&#xD;
             relevant time period).&#xD;
&#xD;
          -  Multiple drug allergies (dermatological, hematological, or organ toxicity) or more&#xD;
             than one severe drug reaction(s).&#xD;
&#xD;
          -  Pregnancy, breastfeeding.&#xD;
&#xD;
          -  Known or suspected hypersensitivity to cannabinoids, or any of the excipients of the&#xD;
             investigational medicinal product.&#xD;
&#xD;
          -  Patients with a history of major depression, suicidal ideation or attempted suicide,&#xD;
             schizophrenia or any other psychotic disorder, patients with a family history of&#xD;
             schizophrenia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>W M Burnham, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Tai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seyed Mirsattari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nancy Mingo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Danielle Andrade, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Campus, London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network - Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epilepsy</keyword>
  <keyword>drug resistant</keyword>
  <keyword>refractory</keyword>
  <keyword>seizures</keyword>
  <keyword>cannabidiol</keyword>
  <keyword>cbd</keyword>
  <keyword>cannabis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Drug Resistant Epilepsy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03808935
org study id: EPL29
nct id: NCT03808935
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine whether a low dose of CBD+THC will decrease the
      frequency of convulsive seizures in adults with drug-resistant epilepsy, when used in
      addition to standard anti-epileptic drugs (AEDs). This study will also study the genes
      associated with epilepsy and whether different epileptic syndromes respond to treatment with
      CBD+THC.
Background: Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) are the two major compounds
      found in the cannabis plant. Reports from patients, families, and the scientific community
      suggest that CBD (when used as an add-on therapy) decreases the number of convulsive seizures
      in children and adults with Dravet syndrome, Lennox-Gastaut syndrome, and Tuberous sclerosis
      complex.

      Trial design: Phase III, double-blind, randomized, placebo-controlled, parallel-group trial,
      followed by an open phase where treatment allocation will be revealed and all participants
      will either continue or begin receiving the active study drug.

      Participants: Adults (18 years of age and older) with drug-resistant epilepsy, including
      patients with Dravet and Lennox Gastaut syndromes, and patients with frequent convulsive
      seizures (e.g., tonic, tonic-clonic, atonic, drop attacks, and focal motor seizures).

      Interventions: Capsules containing a ratio of 16 CBD: 1 THC oil at a maximum total daily dose
      of approximately 300 mg of CBD per day, divided into equal doses in the morning and evening.

      Comparator: Placebo capsules containing high-oleic sunflower oil and no active or medicinal
      ingredients.

      Outcomes: Frequency of seizures; side effects; blood levels of AEDs, CBD, THC, and liver
      enzymes; impact on cognition and quality of life; genetics.

      Sample size: A total of 80 participants (40 assigned to treatment and 40 to control group)
      recruited from Toronto Western Hospital in Toronto, and University Hospital in London,
      Ontario.

      Time: Each participant will be enrolled for approximately 16 to 18 weeks, while the clinical
      trial is expected to take place over a period of two years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Frequency of convulsive seizures
time frame: 0 - 10 weeks
measure: Number of participants with treatment-related adverse events as assessed by the adverse events questionnaire
time frame: 0- 10 weeks
measure: Changes in blood levels of CBD and THC from baseline to end of treatment
time frame: 0 - 10 weeks
measure: Changes in blood levels of AEDs from baseline to end of treatment
time frame: 0 - 10 weeks
measure: Changes in blood levels of liver enzymes AST, ALT, and GGT from baseline to end of treatment
time frame: 0 - 10 weeks
measure: Changes in quality of life from baseline to end of treatment as assessed by the Quality of Life in Epilepsy Inventory (QOLIE-31) questionnaire
time frame: 0 - 10 weeks
description: QOLIE-31 is a 31-item measure assessing health-related quality of life in adults with epilepsy. Seven scales assess seizure worry, overall quality of life, emotional well-being, cognitive and medication effects, and social function.
measure: Changes in quality of life from baseline to end of treatment as assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire
time frame: 0 - 10 weeks
description: WHOQOL-BREF is a 26-item measure of physical health, psychological health, social relationships, and environment.
measure: Changes in quality of life from baseline to end of treatment as assessed by the Quality of Life Childhood Epilepsy (QOLCE) questionnaire
time frame: 0 - 10 weeks
description: QOLCE is a 55-item scale assessing health-related quality of life in children with epilepsy from the perspective of the parent or caregiver. It covers cognitive, emotional, social, and physical functioning.
measure: Changes in symptoms of depression from baseline to end of treatment as assessed by the Neurological Disorder Depression Inventory for Epilepsy (NDDI-E)
time frame: 0 - 10 weeks
description: NDDI-E is a 6-item questionnaire designed to screen for depression in adults with epilepsy.
measure: Changes in symptoms of depression from baseline to end of treatment as assessed by the Quick Inventory of Depressive Symptoms (QIDS)
time frame: 0 - 10 weeks
description: QIDS is a 16-item measure designed to assess the severity of depressive symptoms.
measure: Changes in symptoms of anxiety from baseline to end of treatment as assessed by the Generalized Anxiety Disorder 7-item (GAD-7)
time frame: 0 - 10 weeks
description: GAD-7 is a 7-item questionnaire assessing severity of generalized anxiety disorder.
measure: Change in overall severity of epilepsy from baseline to end of treatment as assessed by the Global Analysis of Severity of Epilepsy Scale (GASE)
time frame: 0 - 10 weeks
description: GASE is a single-item, 7-point global rating scale that was designed to assess the overall severity of epilepsy.
measure: Change in quality of sleep from baseline to end of treatment as assessed by the Pittsburgh Sleep Quality Index (PSQI)
time frame: 0 - 10 weeks
description: PSQI is a 19-item measure assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction.
measure: Change in participant's impression of change from baseline to end of treatment as assessed by the Patients' Global Impression of Change (PGIC) scale
time frame: 0 - 10 weeks
description: PGIC is a 7-point scale assessing the patient's perspective of overall improvement and efficacy of treatment. Scores range from "very much improved" to "very much worse".
measure: Change in caregiver's impression of change from baseline to end of treatment as assessed by the Caregiver's Global Impression of Change (CGIC) scale
time frame: 0 - 10 weeks
description: CGIC is a 7-point scale assessing the caregiver's perspective of overall improvement and efficacy of treatment. Scores range from "very much improved" to "very much worse".
measure: Changes in psychological symptoms from baseline to end of treatment as assessed by the Brief Symptom Inventory (BSI-53)
time frame: 0 - 10 weeks
description: BSI-53 is a 53-item measure assessing psychological profiles. It covers 9 primary domains: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism.
measure: Changes in functional impairment from baseline to end of treatment as assessed by the Sheehan Disability Scale (SDS)
time frame: 0 - 10 weeks
description: SDS is a 5-item measure assessing functional impairment in three inter-related domains: work/school, social, and family life.
arm group label: Medical cannabis
arm group type: Experimental
description: Capsules containing cannabis extract, dissolved in high-oleic sunflower oil, and CBD/THC in a 16:1 ratio.
arm group label: Placebo Control
arm group type: Placebo Comparator
description: Capsules containing a high-oleic sunflower oil, calorie-equated to the active treatment. There will be no active compounds in the placebo treatment.
Following treatment with placebo, all participants in this group will begin treatment with medical cannabis.
intervention type: Drug
intervention name: Medical Cannabis
description: The experimental intervention will begin with two weeks of titration (100 mg to 200 mg of CBD per day), followed by four weeks of treatment (maximum 300 mg of CBD per day) and four weeks of maintenance (maximum 300 mg of CBD per day). A two week washout phase will slowly decrease the daily dose (200 mg to 100 mg of CBD per day). All daily doses are equally divided into a morning and evening dose.
arm group label: Medical cannabis
other name: CBD/THC
intervention type: Drug
intervention name: Placebo
description: The placebo intervention will begin with two weeks of titration, followed by four weeks of treatment. Participants will then be unblinded to their study group and begin two weeks of titration, four weeks of treatment, and two weeks of washout with medical cannabis, following the same dosing and schedule as the experimental group. All daily doses are equally divided into a morning and evening dose.
arm group label: Placebo Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: W M Burnham, PhD
role: Principal Investigator
affiliation: University of Toronto
last name: Peter Tai, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Seyed Mirsattari, MD
role: Principal Investigator
affiliation: London Health Sciences Centre
last name: Nancy Mingo, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Danielle Andrade, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy