Trial Outcomes & Findings for A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome (NCT NCT03458416)
NCT ID: NCT03458416
Last Updated: 2023-06-22
Results Overview
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.
TERMINATED
PHASE2
2 participants
Up to Week 52
2023-06-22
Participant Flow
This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Participants were enrolled in this long-term safety study after completing the INS011-16-085 study. Only 2 participants enrolled in this study. The participants received cannabidiol oral solution (CBD) doses for up to 48 weeks, and a follow-up period of 30 days.
Participant milestones
| Measure |
Cannabidiol Oral Solution
Participants received 20 milligrams (mg)/kilogram (kg)/day to 40 mg/kg/day of CBD given twice daily with standard meals.
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to Week 52Population: This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
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.
Outcome measures
Outcome data not reported
Adverse Events
Cannabidiol Oral Solution
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tarek El Akkad, Head of Clinical Development
Radius Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60