A Study in Adults and Adolescents With Angelman Syndrome (STARS)

Phase 2

Completed

• Conditions: Angelman Syndrome
• Interventions: Drug: OV101 regimen 2; Other: Placebo; Drug: OV101 Regimen 1

• Registration Number: NCT02996305
• Lead Sponsor: Ovid Therapeutics Inc.

Brief Summary

The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol) in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory efficacy outcome measures will be investigated.

Detailed Description

Two dosing schedules of OV101 (gaboxadol) giving as once daily or twice daily dose will be assessed against placebo.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Primary Completion: 2018-06-07
• Study Completion: 2018-08-06
• Status Verified: 2022-03
• Results First Submitted: 2022-03-03
• Results First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Results First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OV101 regimen 2	OV101 regimen 2	OV101 twice daily
Placebo	Placebo	Twice daily
OV101 regimen 1	OV101 Regimen 1	OV101 once daily

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events in Placebo and Active Treatment Groups	Baseline and Week 12	Treatment-related TEAEs (Treatment Emergent Adverse Event) in ≥ 2 Subjects in OV101 Combined, Safety Set. The incidence of TEAEs assessed as treatment-related (at least possibly related to study drug, by the Investigator). Preferred Term in the table below.

Trial Locations

Locations (1)

Ovid Therapeutics Investigative Site; 🇮🇱 Ramat Gan, Israel