A Study of OV101 in Individuals With Fragile X Syndrome

Phase 2

Completed

• Conditions: Fragile X Syndrome (FXS)
• Interventions: Drug: OV101 (gaboxadol)

• Registration Number: NCT03697161
• Lead Sponsor: Ovid Therapeutics Inc.

Brief Summary

The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101 (gaboxadol) in subjects with Fragile X syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-17
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Primary Completion: 2020-02-03
• Study Completion: 2020-02-26
• Results First Submitted: 2022-11-16
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-28
• Last Update Submitted: 2023-12-28
• Results First Posted: 2024-01-23
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Is male and 13 to 22 years old (inclusive) at the time of informed consent.
• Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).

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Exclusion Criteria

• Concomitant disease or condition that are clinically significant and would limit study participation
• Clinically significant lab abnormalities or vital signs at the time of screening
• History of uncontrollable seizure disorder or seizure episodes within 6 months of screening or change in the anticonvulsant pharmacotherapy in the past 3 months.
• Unable or does not have a caregiver able to comply with study requirements.
• Enrolled in any clinical trial within the 30 days before screening.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OV101 (gaboxadol) Regimen 1	OV101 (gaboxadol)	Once Daily
OV101 (gaboxadol) Regimen 2	OV101 (gaboxadol)	Twice Daily
OV101 (gaboxadol) Regimen 3	OV101 (gaboxadol)	Three Times Daily

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAE)	Week 12	Number of Participants with Treatment Emergent Adverse Events

Trial Locations

Locations (1)

Ovid Therapeutics Investigative Site; 🇺🇸 Nashville, Tennessee, United States