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

Use our guide to learn which trials are right for you!

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
5
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-614-8583
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: 319-335-7432
University of Iowa With just over 30,000 students, the University of Iowa is one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
San Diego, California 92123
Phone: 858-966-8453
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Tacoma, Washington 98405
Phone: 253-403-2699
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
Phone: 560-626-5472
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials