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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02844933
• Date of registration: 22/07/2016
• Prospective Registration: Yes
• Primary sponsor: Benuvia Therapeutics Inc.
• Public title: Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi Syndrome
• Scientific 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
• Date of first enrolment: June 6, 2018
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02844933
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ahmed Elkashef, MD
• Affiliation: INSYS Therapeutics Inc

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Intervention(s)

Drug: Cannabidiol

Drug: Placebo

Primary Outcome(s)

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(s)

Change from Baseline in Patient Global Impression of Change and Severity (PGI-C) [Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks)]

Change from Baseline in Physical Activity (PROMIS Physical Activity and Fatigue questionnaires) [Time Frame: Baseline through Study Completion/Early Withdrawal (within 13 weeks)]

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)]

Change from Baseline in Total Body-Weight [Time Frame: Baseline through Study Completion/ Early Withdrawal (within 13 weeks)]

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)]

Responder Rate from Baseline through Study Completion [Time Frame: Baseline through Study Completion (within 13 weeks)]

Secondary ID(s)

INS011-16-085

Source(s) of Monetary Support

Please refer to primary and secondary sponsors