Trials / Completed
CompletedNCT01911455
Study of Acamprosate in Fragile x Syndrome
Double-Blind, Placebo-Controlled Proof of Concept Study in Youth With Fragile X Syndrome
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 5 Years – 23 Years
- Healthy volunteers
- Accepted
Summary
In this research study we want to understand the effectiveness of a drug treatment, acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment) associated with Fragile X Syndrome (FXS).
Detailed description
Each subject with FXS will receive 10 weeks of blinded treatment with acamprosate or matching placebo. After completion of the double-blind phase, all subjects will have an opportunity to receive acamprosate as part of the study procedures for 16 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | acamprosate | |
| DRUG | Placebo |
Timeline
- Start date
- 2013-08-27
- Primary completion
- 2018-11-08
- Completion
- 2018-11-08
- First posted
- 2013-07-30
- Last updated
- 2021-02-03
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01911455. Inclusion in this directory is not an endorsement.