A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome

Prader-Willi Syndrome Clinical Trial

Official title:

A Multicenter, Open-Label Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03458416
• Other study ID #: INS011-17-115
• Status: Terminated
• Phase: Phase 2
• Start date: September 6, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2023
• Source: Radius Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in participants with Prader-Willi Syndrome.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Completed activities up to and including Visit 10 (Study Completion) of INS011-16- 085.

2. 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.

3. If female, is either not of childbearing potential or practicing medically acceptable methods of birth control.

4. Psychotropic treatment will be permitted if the participant has been on a stable dose during the INS011-16-085 and does not anticipate a dose change during the course of the study.

5. Growth hormone treatment will be permitted if the participant has been on a stable dose during INS01-16-085.

6. Any other treatment including thyroid hormones should be stable prior to entering the INS011-17-115 study.

7. 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.

Exclusion Criteria:

1. Participant or parent(s)/caregiver(s) have commitments during the study duration that would interfere with attending all study visits.

2. Experienced an anoxic episode related to study drug requiring resuscitation during the previous study.

3. Uncontrolled Type I and Type II Diabetes.

4. Developed an adverse event thought to be related to CBD in the previous study and the investigator determines that continuing treatment with CBD would not be in the best interest of the partient.

5. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or other condition which would jeopardize safety or impact validity of results (per investigator).

6. Currently taking felbamate.

7. Compromised respiratory function or severe respiratory insufficiency.

8. Pregnant or lactating female.

9. In the opinion of the investigator, the participant is unsuitable in any other way to participate in this study.

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

Drug:
• Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

Locations

Country	Name	City	State
United States	Institute for Research and Innovation | MultiCare Health System	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Radius Pharmaceuticals, Inc.	Benuvia Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Of Adverse Events (AEs) And Serious Adverse Events (SAEs) Associated With Cannabidiol Oral Solution	AE is defined as any untoward medical occurrence in a participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An SAE is defined as any event that results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. A summary of other non-serious AEs and all serious AEs regardless of causality, is located in the Reported AE section.	Up to Week 52