drugset / Trial / NCT03882918

An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome

NCT03882918

Phase 3 Terminated 141 enrolled Healx AI
NaSingle-groupOpen-labelTreatment

Summary

This open-label study (OV101-18-002) will evaluate the long-term (52 weeks) safety of OV101 in subjects with AS and provide additional OV101 treatment to those subjects who completed Study OV101-15-001 (NCT02996305). Subjects with AS who completed the pharmacokinetic Study OV101-16-001 (NCT03109756) will also be permitted to participate, provided they meet all entry criteria.

Timeline

Start
2019-01-31
Primary completion
2021-06-04
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject gaboxadol Small molecule 15 mg

Indications