Summary

for people ages 8-17 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

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 Prader-Willi Syndrome

Keywords

Prader-Willi Syndrome Syndrome Pharmaceutical Solutions Cannabidiol

Eligibility

You can join if…

Open to people ages 8-17

  • 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

You CAN'T join if...

  • 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:
  • the safety or well-being of the participant or study staff;
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  • the analysis of results

Locations

  • Rady Children's, UC San Diego accepting new patients
    San Diego California 92123 United States
  • Institute for Research and Innovation | MultiCare Health System accepting new patients
    Tacoma Washington 98405 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
INSYS Therapeutics Inc
ID
NCT02844933
Phase
Phase 2
Study Type
Interventional
Last Updated