A Study of OV101 in Individuals With Fragile X Syndrome

• Status: Completed
• Trial end date: 2020-02-26
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ovid Therapeutics Inc.
• Treatments: Gaboxadol

Criteria

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).

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.