Phase 2
Completed N=23
A Study of OV101 in Individuals With Fragile X Syndrome
Fragile X Syndrome (FXS)
Source: ClinicalTrials.gov NCT03697161 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAE) — 0; 0; 0; 1 participants
Summary
The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101 (gaboxadol) in subjects with Fragile X syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAE) |
0; 0; 0; 1; 5; 2 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03697161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.