Clinical Trial: Cannabidiol Oral Solution for The Treatment of Subjects With Prader-Willi Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Pra

Brief Summary: The primary objectives of this study are to assess the efficacy of Cannabidiol Oral Solution on hyperphagia-related behavior in subjects with Prader-Willi Syndrome (PWS), and to assess the efficacy of Cannabidiol Oral Solution on body weight in subjects with PWS.

Detailed Summary:
Sponsor: INSYS Therapeutics Inc

Current Primary Outcome:

  • 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) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]


Original Secondary Outcome: Same as current

Information By: INSYS Therapeutics Inc

Dates:
Date Received: July 22, 2016
Date Started: June 2017
Date Completion: December 2017
Last Updated: April 27, 2017
Last Verified: April 2017