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TERMINATEDPHASE2

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome

NCT02844933•Radius Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

8 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant and/or parent(s)/caregiver(s) fully comprehend the informed consent form and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
•Participants with a genetically confirmed diagnosis of Prader-Willi Syndrome using standard deoxyribonucleic acid methylation test or fluorescent in situ hybridization. Documentation of genetically confirmed diagnosis of Prader-Willi Syndrome is acceptable.
•A score of ≥10 on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT).
•A caregiver is available to complete the HQ-CT.
•If female, is either not of childbearing potential (defined as premenarchal or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or practicing one of the following medically acceptable methods of birth control:
•1. Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before study drug administration.
•2. Total abstinence from sexual intercourse since the last menses before study drug administration.
•3. Intrauterine device.
•4. Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
•Adequate hepatic function, defined as total bilirubin ≤ 1.5\*ULN and aspartate aminotransferase and alanine aminotransferase levels ≤ 3\*ULN.
+3 more criteria

Exclusion Criteria

•Known use of cannabis or cannabinoid-containing products for 4 weeks prior to baseline.
•History of chronic liver diseases, such as cirrhosis or chronic hepatitis due to any cause, or suspected alcohol abuse.
•Use of weight loss agents or drugs known to affect appetite (including glucagon-like peptide-1 \[GLP-1\] analogs) within 2 months prior to screening.
•Uncontrolled Type I and Type II diabetes.
•Currently taking concomitant medication that are strong-moderate inhibitors/inducers/sensitive substrates with a narrow therapeutic index for CYP2C19 or CYP3A.
•Co-morbid condition or disease (such as respiratory disease, heart disease, or psychiatric disorder) diagnosed less than 1 month prior to screening.
•History or presence of gastrointestinal or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs as determined by the Investigator.
•Participants who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.
•Clinically significant abnormalities on electrocardiogram at screening or other evidence of heart disease as determined by the Investigator.
•Has screening systolic blood pressure ≥160 millimeters of mercury (mmHg) and diastolic blood pressure \>100 mm Hg (may be repeated 1 additional time after 5 minutes rest to verify). Participants with hypertensive levels lower than those specified may be excluded at the Investigator's discretion if deemed to be in the best interest of the participant.
+8 more criteria

Locations (7)

University of Arizona

Tucson, Arizona, United States

Rady Children's, UC San Diego

San Diego, California, United States

University of Iowa

Iowa City, Iowa, United States

The University of Kansas , Medical Center

Kansas City, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

The University of Oklahoma Health Sciences Center

Tulsa, Oklahoma, United States

Institute for Research and Innovation | MultiCare Health System

Tacoma, Washington, United States

Key Dates

Start Date

May 9, 2018

Primary Completion Date

July 17, 2019

Completion Date

July 31, 2019

Last Updated

August 1, 2023

Enrollment

ACTUAL participants

Conditions

Prader-Willi Syndrome

Interventions

Cannabidiol

DRUG

Placebo

DRUG

Institutional Registry of Rare Diseases

NCT06573723

Rare DiseasesAmyloidosis+24 more

View study

RECRUITING

Register of Patients With Prader-Willi Syndrome

NCT02829684

Prader-Willi Syndrome

View study

RECRUITING

GROWing Up With Rare GENEtic Syndromes

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Institutional Registry of Rare Diseases

Register of Patients With Prader-Willi Syndrome

GROWing Up With Rare GENEtic Syndromes

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