Summary

for males ages 13-22 (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Fragile X Syndrome (FXS) Syndrome Fragile X Syndrome Gaboxadol OV101 (gaboxadol)

Eligibility

You can join if…

Open to males ages 13-22

  • 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).

You CAN'T join if...

  • 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.

Locations

  • Ovid Therapeutics Investigative Site accepting new patients
    Sacramento California 95817 United States
  • Ovid Therapeutics Investigative Site accepting new patients
    Phoenix Arizona 85006 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ovid Therapeutics Inc.
Links
Sign up for this study
ID
NCT03697161
Phase
Phase 2
Study Type
Interventional
Last Updated