Study of Acamprosate in Fragile x Syndrome

Status:	Active, not recruiting
Conditions:	Other Indications
Therapuetic Areas:	Other
Healthy:	No
Age Range:	5 - 23
Updated:	2/13/2019
Start Date:	June 2013
End Date:	June 2020

Double-Blind, Placebo-Controlled Proof of Concept Study in Youth With Fragile X Syndrome

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).

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.

Inclusion Criteria:

- Diagnostic confirmation of full mutation FXS

- Age ≥5 years and <23 years

- General good health as determined by physical exam, medical history and laboratory
work up.

Exclusion Criteria:

- Use of more than two psychotropic medications (medications affecting behavior).

- Unstable dosing of any psychotropic medication (medication affecting behavior)

- Problems with kidney functioning

- Unstable seizure disorder

- Change in any anti-convulsant drug dosing in the 60 days prior to study entry

- Prior adequate treatment trial with acamprosate as determined by the study doctor

- Pregnant or lactating females

We found this trial at

sites

Cincinnati Children's Hospital Medical Center

3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229

1-513-636-4200