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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 : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

July 22, 2016
July 26, 2016
December 4, 2018
June 6, 2018
June 2019   (Final data collection date for primary outcome measure)
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) ]
  • 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) ]
Complete list of historical versions of study NCT02844933 on ClinicalTrials.gov Archive Site
  • 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) ]
  • 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) ]
Not Provided
Not Provided
 
Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi Syndrome
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Prader-Willi Syndrome
  • Drug: Cannabidiol
    Oral solution
  • Drug: Placebo
    Matching oral solution
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
Same as current
June 2019
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact: Clinical Operations (602) 910-2617 InsysCBD@insysrx.com
United States
 
 
NCT02844933
INS011-16-085
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
INSYS Therapeutics Inc
INSYS Therapeutics Inc
Not Provided
Study Director: Giovanni DeCastro INSYS Therapeutics Inc
INSYS Therapeutics Inc
December 2018

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