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

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ClinicalTrials.gov Identifier: NCT02844933
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Drug: Cannabidiol Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cannabidiol
Cannabidiol oral solution (40 mg/kg/day) divided into two daily doses with a standard meal
Drug: Cannabidiol
Oral solution

Placebo Comparator: Placebo
Matching placebo solution divided into two daily doses with a standard meal
Drug: Placebo
Matching oral solution




Primary Outcome Measures :
  1. Change from Baseline in the total score of the Hyperphagia Questionnaire for Clinical Trial (HQ-CT) [ Time Frame: Baseline through Study Completion/ Early Withdrawal (within 13 weeks) ]

Secondary Outcome Measures :
  1. Change from Baseline in Total Body-Weight [ Time Frame: Baseline through Study Completion/ Early Withdrawal (within 13 weeks) ]
  2. Responder Rate from Baseline through Study Completion [ Time Frame: Baseline through Study Completion (within 13 weeks) ]
    Responder is defined as 6-point decrease on the HQ-CT

  3. Change from Baseline in Patient Global Impression of Change and Severity (PGI-C) [ Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks) ]
  4. Change from Baseline in the Three Factor Eating Questionnaire - 18-item Version (TFEQ-R18) [ Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks) ]
  5. Change from Baseline in Quality of Life (PROMIS Life Satisfaction and Positive Affect Questionnaires) [ Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks) ]
  6. Change from Baseline in Physical Activity (PROMIS Physical Activity and Fatigue questionnaires) [ Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks) ]


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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844933


Contacts
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Contact: Clinical Operations (602) 910-2617 InsysCBD@insysrx.com

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Research Coordinator    560-626-5472    mgordon@email.arizona.edu   
United States, California
Rady Children's, UC San Diego Recruiting
San Diego, California, United States, 92123
Contact: Research Coordinator    858-966-8453    rwinograd@rchsd.org   
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Research Coordinator    319-335-7432    rachel-bisbee@uiowa.edu   
United States, Kansas
The University of Kansas , Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Research Coordinator    913-588-1800    cweber3@kumc.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Research Coordinator    410-614-8583    kfehily2@jhmi.edu   
United States, Oklahoma
The University of Oklahoma Health Sciences Center Recruiting
Tulsa, Oklahoma, United States, 74135
Contact: Research Coordinator    918-619-4304    Sharnella-Goudeau@ouhsc.edu   
United States, Washington
Institute for Research and Innovation | MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact: Research Coordinator    253-403-2699    ccanorro@multicare.org   
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Ahmed Elkashef, MD INSYS Therapeutics Inc

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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02844933     History of Changes
Other Study ID Numbers: INS011-16-085
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Epidiolex
Pharmaceutical Solutions
Anticonvulsants