Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Sep 2018

Shorter than P25 for phase_2

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

September 17, 2018

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed

23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed

3.9 years until next milestone

Results Posted

Study results publicly available

January 23, 2024

Completed

Last Updated

January 23, 2024

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

October 1, 2018

Results QC Date

November 16, 2022

Last Update Submit

December 28, 2023

Conditions

Fragile X Syndrome (FXS)

Outcome Measures

Primary Outcomes (1)

Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number of Participants with Treatment Emergent Adverse Events
Week 12

Other Outcomes (1)

Clinical Global Impressions- Improvement (CGI-I)
Week 12

Study Arms (3)

OV101 (gaboxadol) Regimen 1

EXPERIMENTAL

Once Daily

Drug: OV101 (gaboxadol)

OV101 (gaboxadol) Regimen 2

EXPERIMENTAL

Twice Daily

Drug: OV101 (gaboxadol)

OV101 (gaboxadol) Regimen 3

EXPERIMENTAL

Three Times Daily

Drug: OV101 (gaboxadol)

Interventions

OV101 (gaboxadol)DRUG

OV101 (gaboxadol)

OV101 (gaboxadol) Regimen 1OV101 (gaboxadol) Regimen 2OV101 (gaboxadol) Regimen 3

Eligibility Criteria

Age13 Years - 22 Years

Sexmale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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 may not qualify 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.

Contact the study team to confirm eligibility.