A Study of OV101 in Individuals With Fragile X Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2020-02-26

Brief Summary

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

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Detailed Description

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Conditions

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Fragile X Syndrome (FXS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OV101 (gaboxadol) Regimen 1

Once Daily

Group Type EXPERIMENTAL

OV101 (gaboxadol)

Intervention Type DRUG

OV101 (gaboxadol)

OV101 (gaboxadol) Regimen 2

Twice Daily

Group Type EXPERIMENTAL

OV101 (gaboxadol)

Intervention Type DRUG

OV101 (gaboxadol)

OV101 (gaboxadol) Regimen 3

Three Times Daily

Group Type EXPERIMENTAL

OV101 (gaboxadol)

Intervention Type DRUG

OV101 (gaboxadol)

Interventions

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OV101 (gaboxadol)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

22 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No