Study Purpose
Insys Development Company, Inc. is conducting a clinical trial to determine if the use of Cannabidiol (CBD) is safe and effective in the treatment of Prader-Willi Syndrome. The trial will evaluate whether the use of CBD, provided as an oral solution, can help control hyperphagia and compulsive behaviors. Patients will receive either Cannabidiol oral solution or placebo, divided into two daily doses to be given alongside a standard meal.
Recruitment Criteria
Study Type: Randomized, double-blind, placebo-controlled
Eligible Ages: 8 to 17 years
Other Criteria:
Trial Details
Trial Id: NCT02844933
Phase: 2
Duration: 13 weeks
Status: recruiting
Lead Sponsor: Insys
Countries: United States
Additional Details:
Eligibility Criteria
Inclusion Criteria:
- Meets protocol-specified criteria for qualification and contraception
- Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
- 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:
- 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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. More information on this study is available on the study information page at clincaltrials.gov.
This Study is enrolling at the following sites:
1112 6th Ave., Suite 100, Tacoma, WA 98405
Rady Children's, UC San Diego
7910 Frost St #270, San Diego, CA 92123
PI: Lynne Bird, MD
Research Coordinator: Rachel Winograd
rwinograd@rchsd.org
1- 858-966-8453
The following sites will be available soon:
University of Arizona
1501 N. Campbell Avenue, Tucson, AZ 85724-5093
PI: Christina Laukaitis, MD
Research Coordinator: Maria Gordon
mgordon@email.arizona.edu
1-520-626-8000
Children’s Hospital of Orange County
1201 W La Veta Avenue, Orange, CA 92868
PI: Sejal Kadakia, MD
Research Coordinator: Heather Speer
hspeer@choc.org
714-509-8613
St. Luke’s Health System
125 E. Idaho St. Suite 200, Boise ID 83712
PI: Daniel Flynn, MD
Research Coordinator: Xanti Gerrard
gerrardx@slhs.org
208-381-9433
University of Iowa
200 Hawkins Drive, 2015BT, Iowa City, IA 52242
PI: Eva Tsalikian, MD
Research Coordinator: Julie Coffey
julie-coffey@uiowa.edu
1- 319-384-4653
University of Kansas Medical Center
3901 Rainbow Boulevard, Mailstop 4015, Kansas City KS 66160
PI: Ann Genovese, MD & Merlin Butler, MD
Research Coordinator: Yolanda Harness
yharness@kumc.edu
1-913-574-0302
600 N. Wolfe Street CMSC 2-1116, Baltimore, MD 21287
PI: Ann Scheimann, MD
Research Coordinator: Kim Kafka
kfehily2@jhmi.edu
1-410-614-8583
Boston Children’s Hospital
Division of Endocrinology, 300 Longwood Avenue, Boston, MA 02115
PI: Amy Fleischman, MD
Research Coordinator: Andrea Hale
andrea.hale@childrens.harvard.edu
1-617-919-2867
University of Oklahoma Health Sciences Center (OUHSC)
4444 E. 41st St., Suite SCC 1B, Tulsa, OK 74135
PI: Laura Chalmers, MD
Research Coordinator: Julia Crawford
julia-crawford@ouhsc.edu
1-918-619-4803
Le Bonheur Children's Hospital - UT
Le Bonheur Pediatric Specialists – Memphis
848 Adams Ave, Memphis, TN 38103
PI: Joan Han, MD
Research Coordinator: Raquel Mack
rmack7@uthsc.edu
1-901-287-6869
