A Study of OV101 in Individuals With Fragile X Syndrome



Status:Recruiting
Healthy:No
Age Range:13 - 22
Updated:3/30/2019
Start Date:September 17, 2018
End Date:September 2019

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A Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X Syndrome

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


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.
We found this trial at
8
sites
Media, Pennsylvania
Phone: 610-891-9699
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Aurora, Colorado 80045
Phone: 720-777-8087
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Aurora, CO
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Baltimore, Maryland 21205
Phone: 312-942-4036
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Baltimore, MD
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Chicago, Illinois
Phone: 312-942-4036
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Chicago, IL
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Cincinnati, Ohio
Phone: 312-942-4036
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Cincinnati, OH
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Nashville, Tennessee
Phone: 615-343-6547
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Nashville, TN
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Phoenix, Arizona
Phone: 480-443-4018
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Phoenix, AZ
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Sacramento, California 95817
Phone: 916-703-0280
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Sacramento, CA
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