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

• Status: Terminated
• Trial end date: 2019-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benuvia Therapeutics Inc.; INSYS Therapeutics Inc
• Treatments: Cannabidiol; Pharmaceutical Solutions

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