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

NCT02844933 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-08-01

Study results available
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Summary

The primary objective of this study is to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients 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 patients with PWS.

Conditions

Interventions

DRUG

Cannabidiol

Oral solution

DRUG

Placebo

Matching oral solution

Sponsors & Collaborators

  • Radius Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Ahmed Elkashef, MD · INSYS Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2019-07-17
Completion
2019-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02844933 on ClinicalTrials.gov