Status:
COMPLETED
Study of Acamprosate in Autism
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Autism Speaks
Conditions:
Autistic Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
Brief Summary
Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability that commonly ...
Detailed Description
Each subject with ASD 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
- 5-17 year-old outpatients
- Diagnosis of ASD
- General good health (determined by exam, history, and laboratory work up)
- Use of up to two concomitant psychotropic drugs (stable dosing for \>60 days) not impacting glutamate or gamma-aminobutyric acid A (GABA) neurotransmission is allowed
- Stable seizure disorder (no seizures in 6 months; on same anti-convulsant dose for \>60 days)
- Clinical Global Impression Scale Severity score (CGI-S) of 4 (Moderately III)
- Score of 13 on the Social Withdrawal subscale of the Aberrant Behavior Checklist (ABC-SW) at screen and baseline
Exclusion
- Potential subjects with a creatinine clearance \< 50 mL/min or evidence of a previous trial of acamprosate will be excluded
Key Trial Info
Start Date :
July 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01813318
Start Date
July 2 2013
End Date
September 7 2017
Last Update
February 3 2021
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229