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

Status:	Recruiting
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	8 - 17
Updated:	4/5/2019
Start Date:	June 6, 2018
End Date:	June 2019
Contact:	Clinical Operations
Email:	InsysCBD@insysrx.com
Phone:	(602) 910-2617

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.

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

We found this trial at

sites

University of Arizona

Tucson, Arizona 85721

(520) 621-2211