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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 : Not yet recruiting
First Posted : July 26, 2016
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objectives of this study are to assess the efficacy of Cannabidiol Oral Solution on hyperphagia-related behavior in subjects with Prader-Willi Syndrome (PWS), and to assess the efficacy of Cannabidiol Oral Solution on body weight in subjects with PWS.

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

Study Design

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
Anticipated Study Start Date : January 30, 2018
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cannabidiol
Cannabidiol oral solution 40 mg/kg/day (maximum dose of 3000 mg/day) divided into two daily doses within 30 minutes of a meal
Drug: Cannabidiol
Oral solution
Placebo Comparator: Placebo
Matching placebo solution divided into two daily doses within 30 minutes of a meal
Drug: Placebo
Matching oral solution


Outcome Measures

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

Secondary Outcome Measures :
  1. Change in the Three Factor Eating Questionnaire (TFEQ) from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks) ]
  2. Change in the Development Behavior Checklist (DBC) from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks) ]
  3. Change in Skin Picking Impact Scale (SPIS) from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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

Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
Study Director: Giovanni DeCastro INSYS Therapeutics Inc
More Information

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: January 4, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Prader-Willi 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
Pharmaceutical Solutions