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drugset / Trial / NCT03458416

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

NCT03458416 ↗

Phase 2 Terminated 2 enrolled Radius Pharmaceuticals, Inc. Benuvia Therapeutics Inc. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-09-06
Primary completion
2019-07-31
Completion
2019-07-31

Outcome

Outcome not reported

Stopped: “Insys Therapeutics filed Chapter 11 and terminated all studies.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 20 mg/kg Oral
Subject Cannabidiol Other / unclassified 30 mg/kg Oral
Subject Cannabidiol Other / unclassified 40 mg/kg Oral

Indications

Prader-Willi syndrome