A Study of OV101 in Individuals With Fragile X Syndrome

NCT03697161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-01-23

Study results available
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Summary

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

Conditions

  • Fragile X Syndrome (FXS)

Interventions

DRUG

OV101 (gaboxadol)

OV101 (gaboxadol)

Sponsors & Collaborators

  • Healx AI

    lead INDUSTRY

Principal Investigators

  • Amit Rakhit, MD · Healx AI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
22 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2020-02-03
Completion
2020-02-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03697161 on ClinicalTrials.gov