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Small Molecule

OV101 for 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

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 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 52 for reporting.

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

Side effects data

From 2020 Phase 3 trial • 104 Patients • NCT04106557
14%
Pyrexia
14%
URI
14%
Contusion
14%
Ear Infection
14%
Somnolence
14%
Insomnia
14%
Lethargy
14%
Diarrhea
14%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
OV101 Once Daily (Weight-based Dosing) Age 2-3
OV101 Once Daily (Weight-based Dosing) Other Name:Gaboxadol
Placebo Once Daily

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
~19 spots leftby Oct 2025
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