Phase 2
N=23
A Study of OV101 in Individuals With Fragile X Syndrome
Fragile X Syndrome (FXS)
Bottom Line
View on ClinicalTrials.gov: NCT03697161 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAE) — 0; 0; 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OV101 (gaboxadol) (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- Male
- Sponsor
- Healx AI
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAE) |
0; 0; 0; 1; 5; 2 | — |
Summary
The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101 (gaboxadol) in subjects with Fragile X syndrome.
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.