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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2017 by INSYS Therapeutics Inc
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT02844933
First received: July 22, 2016
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Prader-Willi Syndrome Drug: Cannabidiol Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by INSYS Therapeutics Inc:

Primary Outcome Measures:
  • 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 ]
  • Change in total body-weight from Baseline through Study Completion/Withdrawal [ Time Frame: Baseline through Study Completion/Withdrawal (within 13 weeks) ]

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

Estimated Enrollment: 66
Anticipated Study Start Date: June 30, 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 22, 2016
Last Updated: May 30, 2017

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

ClinicalTrials.gov processed this record on June 28, 2017