<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/NCT02225639</url>
  </required_header>
  <id_info>
    <org_study_id>063-008</org_study_id>
    <nct_id>NCT02225639</nct_id>
  </id_info>
  <brief_title>PRC-063 in an ADULT Workplace Environment</brief_title>
  <official_title>A Randomized, Double-blind Study of the Time Course of Response of PRC-063 in Adults With ADHD in a Simulated Adult Workplace Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhodes Pharmaceuticals, L.P.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Purdue Pharma LP</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhodes Pharmaceuticals, L.P.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess the time of onset and time course of&#xD;
      efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a&#xD;
      simulated adult workplace environment (AWE) setting, as measured by the PERMP (an&#xD;
      individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours&#xD;
      post-dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, crossover, placebo-controlled, optimized-dose, phase 3&#xD;
      study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride&#xD;
      controlled-release capsules 25, 35, 45, 55, 70, 85 or 100 mg/day) in the treatment of&#xD;
      Attention-Deficit/Hyperactivity Disorder (ADHD) in adult subjects greater than or equal to 18&#xD;
      years of age and less than or equal to 60 years of age. After giving written informed&#xD;
      consent, subjects will be screened to ascertain their suitability for the study according to&#xD;
      the inclusion and exclusion criteria. The study will have four phases: (1) Screening and&#xD;
      subsequent washout, if needed; (2) baseline and open-label dose optimization during which&#xD;
      subjects will be titrated from a starting dose of 25 mg up to his/her final dose (25, 35, 45,&#xD;
      55, 70, 85 or 100 mg/day); (3) AWE sessions 1 and 2 in the adult analog setting following a&#xD;
      practice session; and (4) 14-day safety follow-up. Subjects will be required to visit the&#xD;
      clinic up to 10 times over a 9-week period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Permanent Product Measure of Performance (PERMP)</measure>
    <time_frame>Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observer-rated SKAMP</measure>
    <time_frame>Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician-administered ADHD-5-Rating Scale</measure>
    <time_frame>12.0 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions of Improvement (CGI-I)</measure>
    <time_frame>Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject-rated Conners' Adult ADHD Rating Scale (CAARS)</measure>
    <time_frame>12.0 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report of the Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Survey (PSS)</measure>
    <time_frame>Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Occurrence of treatment-emergent adverse events and specific evaluation of blood pressure, heart rate, electrocardiogram (ECG), laboratory findings and physical examination (PE).</measure>
    <time_frame>Controlled phase and 14-day safety followup</time_frame>
    <description>AWE sessions 1 and 2 in the adult analog setting following a practice session; and (4) 14-day safety follow-up. Subjects will be required to visit the clinic up to 10 times over a 9-week period.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder (ADHD)</condition>
  <arm_group>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRC-063 25 mg</intervention_name>
    <description>Oral 25 mg capsule - active</description>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>25 mg capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral placebo capsule</description>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRC-063 35 mg</intervention_name>
    <description>Oral 35 mg capsule - active</description>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>35 mg capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRC-063 45 mg</intervention_name>
    <description>Oral 45 mg capsule - active</description>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>45 mg capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRC-063 55 mg</intervention_name>
    <description>Oral 55 mg capsule - active</description>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>55 mg capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRC-063 70 mg</intervention_name>
    <description>Oral 70 mg capsule - active</description>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>70 mg capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRC-063 85 mg</intervention_name>
    <description>Oral 85 mg capsule - active</description>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>85 mg capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRC-063 100 mg</intervention_name>
    <description>Oral 100 mg capsule - active</description>
    <arm_group_label>PRC-063</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>100 mg capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be male or non-pregnant female at least 18 years of age and less than or equal to&#xD;
             60 years of age.&#xD;
&#xD;
          -  Must have an ADHD diagnosis, in attentive, hyperactive/impulsive or combined, as&#xD;
             defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition&#xD;
             (DSM-5) based on clinician assessment using multiple informants and a structured&#xD;
             interview.&#xD;
&#xD;
          -  Clinician-completed ADHD-5-RS total score must be equal to or greater than 24, as&#xD;
             assessed at Visit 2a.&#xD;
&#xD;
          -  Must be unsatisfied with his or her current pharmacological therapy for treatment of&#xD;
             ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of&#xD;
             subjects naïve to pharmacological therapy for ADHD is permitted.&#xD;
&#xD;
          -  Female subjects must be one of the following: a. surgically sterile prior to&#xD;
             screening; b. if of childbearing potential, abstinent or willing to use a reliable&#xD;
             method of contraception, such as oral contraceptive, two barrier methods, a barrier&#xD;
             method plus a spermicidal agent.&#xD;
&#xD;
          -  Female subjects of Child-Bearing Potential (FOCP) must be a negative serum β-hCG&#xD;
             pregnancy test at screening.&#xD;
&#xD;
          -  Must have a minimum level of intellectual functioning, as determined by an&#xD;
             Intelligence Quotient (IQ) score of 80 or above based on the KBIT-2.&#xD;
&#xD;
          -  Mentally and physically competent to sign an informed assent document, in the case of&#xD;
             the subject, and an informed consent document, in the case of the parent/guardian,&#xD;
             indicating that they understand the purpose of and procedures required for the study&#xD;
             and are willing to participate in the study.&#xD;
&#xD;
          -  Able and willing to comply with the study procedures for the entire length of the&#xD;
             study, including a successful swallow test of an empty 100 mg capsule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having an allergy to methylphenidate or amphetamines or a history of serious adverse&#xD;
             reactions to methylphenidate.&#xD;
&#xD;
          -  Known to be non-responsive to methylphenidate treatment. Non-response is defined as&#xD;
             methylphenidate use at various doses for a phase of at least four weeks at each dose&#xD;
             with little or no clinical benefit in the last 10 years.&#xD;
&#xD;
          -  Being diagnosed with or having a history of strokes, epilepsy, migraine headaches&#xD;
             (greater than 1 instance every two months), glaucoma, thyrotoxicosis, tachyarrhythmias&#xD;
             or severe angina pectoris or have serious or unstable medical illness. Subjects with&#xD;
             controlled or stable asthma or diabetes will be permitted.&#xD;
&#xD;
          -  Elevated blood pressure, defined as any values above 89 diastolic or 139 systolic, as&#xD;
             assessed at Visit 1.&#xD;
&#xD;
          -  Clinically significant ECG abnormalities, as assessed at Visit 1.&#xD;
&#xD;
          -  Clinically significant laboratory abnormalities, as assessed at Visit 1.&#xD;
&#xD;
          -  Currently receiving guanethidine, pressor agents, MAO inhibitors, coumarin&#xD;
             anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone),&#xD;
             phenylbutazone, tricyclic antidepressants (e.g., imipramine, desipramine), selective&#xD;
             serotonin reuptake inhibitors (SSRIs) or herbal remedies (unless on a stable dose for&#xD;
             4 weeks).&#xD;
&#xD;
          -  Subject has known history of symptomatic cardiovascular disease, advanced&#xD;
             arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm&#xD;
             abnormalities, coronary heart disease, transient ischemic attack or stroke or other&#xD;
             serious cardiac problems that may place the subject at increased vulnerability to the&#xD;
             sympathomimetic effects of a stimulant drug.&#xD;
&#xD;
          -  Subject has a known family history of sudden cardiac death or ventricular arrhythmia.&#xD;
&#xD;
          -  Subjects who are currently considered a suicide risk by the investigator.&#xD;
&#xD;
          -  Having a primary diagnosis of schizophrenia, schizoaffective disorder, primary&#xD;
             affective disorder, schizotypal personality, major depression, bipolar disorder,&#xD;
             generalized anxiety, borderline personality disorder, antisocial personality or&#xD;
             another unstable psychiatric condition requiring treatment, as assessed by the&#xD;
             structured interview conducted at Visit 1.&#xD;
&#xD;
          -  Having a history or suspected physiological dependence within the past 5 years&#xD;
             (excluding nicotine) on narcotic analgesics or other psychoactive drugs (including&#xD;
             barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines).&#xD;
&#xD;
          -  Excessive consumption of alcohol (consumes alcohol in quantities greater than 15&#xD;
             drinks per week; 1 drink is defined as 360 mL/12 oz. of beer, 120 mL/4 oz. of wine, or&#xD;
             30 mL/1 oz. of hard liquor), or history (within previous 6 months) of alcohol abuse.&#xD;
&#xD;
          -  Currently (or within 30 days before the planned start of treatment) receiving an&#xD;
             investigational drug or using an experimental medical device.&#xD;
&#xD;
          -  Homeless.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AVIDA, Inc.</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Psychiatry and Behavioral Medicine Inc.</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>July 7, 2015</last_update_submitted>
  <last_update_submitted_qc>July 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>Adult</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</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/NCT02225639
org study id: 063-008
nct id: NCT02225639
lead sponsor: 
collaborator: 
has dmc: No
The primary objective of this study is to assess the time of onset and time course of
      efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a
      simulated adult workplace environment (AWE) setting, as measured by the PERMP (an
      individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours
      post-dose.
This is a randomized, double-blind, crossover, placebo-controlled, optimized-dose, phase 3
      study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride
      controlled-release capsules 25, 35, 45, 55, 70, 85 or 100 mg/day) in the treatment of
      Attention-Deficit/Hyperactivity Disorder (ADHD) in adult subjects greater than or equal to 18
      years of age and less than or equal to 60 years of age. After giving written informed
      consent, subjects will be screened to ascertain their suitability for the study according to
      the inclusion and exclusion criteria. The study will have four phases: (1) Screening and
      subsequent washout, if needed; (2) baseline and open-label dose optimization during which
      subjects will be titrated from a starting dose of 25 mg up to his/her final dose (25, 35, 45,
      55, 70, 85 or 100 mg/day); (3) AWE sessions 1 and 2 in the adult analog setting following a
      practice session; and (4) 14-day safety follow-up. Subjects will be required to visit the
      clinic up to 10 times over a 9-week period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Permanent Product Measure of Performance (PERMP)
time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
measure: Observer-rated SKAMP
time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
measure: Clinician-administered ADHD-5-Rating Scale
time frame: 12.0 hours post-dose
measure: Clinical Global Impressions of Improvement (CGI-I)
time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
measure: Subject-rated Conners' Adult ADHD Rating Scale (CAARS)
time frame: 12.0 hours post-dose
measure: Self-report of the Pittsburgh Sleep Quality Index (PSQI)
time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
measure: Patient Satisfaction Survey (PSS)
time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
measure: Occurrence of treatment-emergent adverse events and specific evaluation of blood pressure, heart rate, electrocardiogram (ECG), laboratory findings and physical examination (PE).
time frame: Controlled phase and 14-day safety followup
description: AWE sessions 1 and 2 in the adult analog setting following a practice session; and (4) 14-day safety follow-up. Subjects will be required to visit the clinic up to 10 times over a 9-week period.
arm group label: PRC-063
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PRC-063 25 mg
description: Oral 25 mg capsule - active
arm group label: PRC-063
arm group label: Placebo
other name: 25 mg capsule
intervention type: Drug
intervention name: Placebo
description: Oral placebo capsule
arm group label: PRC-063
arm group label: Placebo
other name: Placebo capsule
intervention type: Drug
intervention name: PRC-063 35 mg
description: Oral 35 mg capsule - active
arm group label: PRC-063
arm group label: Placebo
other name: 35 mg capsule
intervention type: Drug
intervention name: PRC-063 45 mg
description: Oral 45 mg capsule - active
arm group label: PRC-063
arm group label: Placebo
other name: 45 mg capsule
intervention type: Drug
intervention name: PRC-063 55 mg
description: Oral 55 mg capsule - active
arm group label: PRC-063
arm group label: Placebo
other name: 55 mg capsule
intervention type: Drug
intervention name: PRC-063 70 mg
description: Oral 70 mg capsule - active
arm group label: PRC-063
arm group label: Placebo
other name: 70 mg capsule
intervention type: Drug
intervention name: PRC-063 85 mg
description: Oral 85 mg capsule - active
arm group label: PRC-063
arm group label: Placebo
other name: 85 mg capsule
intervention type: Drug
intervention name: PRC-063 100 mg
description: Oral 100 mg capsule - active
arm group label: PRC-063
arm group label: Placebo
other name: 100 mg capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Attention Deficit Disorder with Hyperactivity