Insys conducting a clinical trial on the use of Cannabidiol in PWS

Study Purpose

Insys Development Company, Inc. is conducting a clinical trial to determine if the use of Cannabidiol (CDB) 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 IdNCT02844933
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:
    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

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:

Institute for Research and Innovation | MultiCare Health System
1112 6th Ave., Suite 100, Tacoma, WA 98405
PI: Gad Kletter, MD
Research Coordinator: Katy Garrison
1-253-403-2699

The following sites will be available soon:

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
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
 
Johns Hopkins University Children's Center
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

 

 

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