Overview

Study of Acamprosate in Fragile x Syndrome

Status:
Completed

Trial end date:
2018-11-08

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Children's Hospital Medical Center, Cincinnati

Collaborator:

Rush University Medical Center

Treatments:

Acamprosate

Criteria

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