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Small Molecule
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome (ELARA Trial)
Phase 3
Waitlist Available
Research Sponsored by Ovid Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests the safety and effectiveness of OV101 in patients with Angelman Syndrome who have already participated in earlier studies. The goal is to see if OV101 can help improve their behavior, sleep, and daily functioning over time.
Eligible Conditions
- Angelman Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events in active treatment group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: OV101Experimental Treatment1 Intervention
once daily at bedtime (gaboxadol)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OV101
2017
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Ovid Therapeutics Inc.Lead Sponsor
7 Previous Clinical Trials
419 Total Patients Enrolled
3 Trials studying Angelman Syndrome
204 Patients Enrolled for Angelman Syndrome