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Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi Syndrome

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ClinicalTrials.gov Identifier: NCT02844933
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE July 22, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE June 6, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
Change from Baseline in the total score of the Hyperphagia Questionnaire for Clinical Trial (HQ-CT) [ Time Frame: Baseline through Study Completion/ Early Withdrawal (within 13 weeks) ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
  • Change in the total score of the Hyperphagia Questionnaire for Clinical Trial (HQ-CT) from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks ]
  • Change in total body-weight from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks) ]
Change History Complete list of historical versions of study NCT02844933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
  • Change from Baseline in Total Body-Weight [ Time Frame: Baseline through Study Completion/ Early Withdrawal (within 13 weeks) ]
  • Responder Rate from Baseline through Study Completion [ Time Frame: Baseline through Study Completion (within 13 weeks) ]
    Responder is defined as 6-point decrease on the HQ-CT
  • Change from Baseline in Patient Global Impression of Change and Severity (PGI-C) [ Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks) ]
  • Change from Baseline in the Three Factor Eating Questionnaire - 18-item Version (TFEQ-R18) [ Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks) ]
  • Change from Baseline in Quality of Life (PROMIS Life Satisfaction and Positive Affect Questionnaires) [ Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks) ]
  • Change from Baseline in Physical Activity (PROMIS Physical Activity and Fatigue questionnaires) [ Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
  • Change in the Three Factor Eating Questionnaire (TFEQ) from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks) ]
  • Change in the Development Behavior Checklist (DBC) from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks) ]
  • Change in Skin Picking Impact Scale (SPIS) from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi Syndrome
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi Syndrome
Brief Summary The primary objective of this study is to assess the efficacy of Cannabidiol Oral Solution on hyperphagia-related behavior in subjects with Prader-Willi Syndrome (PWS). The secondary objectives of this study are to assess the efficacy, safety and tolerability, impact on quality of life, and impact on physical activity of Cannabidiol Oral Solution in subjects with PWS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prader-Willi Syndrome
Intervention  ICMJE
  • Drug: Cannabidiol
    Oral solution
  • Drug: Placebo
    Matching oral solution
Study Arms  ICMJE
  • Experimental: Cannabidiol
    Cannabidiol oral solution (40 mg/kg/day) divided into two daily doses with a standard meal
    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo
    Matching placebo solution divided into two daily doses with a standard meal
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2016)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets protocol-specified criteria for qualification and contraception
  • In the opinion of the investigator, the parent(s)/caregiver(s) is (are) willing and able to comply with the study procedures and visit schedules, including venipuncture, and the visit schedules
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

  • History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
  • Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

    1. the safety or well-being of the participant or study staff;
    2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
    3. the analysis of results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Operations (602) 910-2617 InsysCBD@insysrx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02844933
Other Study ID Numbers  ICMJE INS011-16-085
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party INSYS Therapeutics Inc
Study Sponsor  ICMJE INSYS Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ahmed Elkashef, MD INSYS Therapeutics Inc
PRS Account INSYS Therapeutics Inc
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP