Status:
COMPLETED
Study of Acamprosate in Fragile x Syndrome
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Rush University Medical Center
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
5-23 years
Phase:
PHASE1
Brief 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...
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 acam...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01911455
Start Date
August 27 2013
End Date
November 8 2018
Last Update
February 3 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229