Study of Acamprosate in Autism

Completed · Phase 1 · Has a placebo group

Conditions studied: Autistic Disorder

In brief

Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability that commonly occur in persons with ASD. Despite over two decades of significant pharmacotherapy research, to date no medication has been shown in controlled trials to enhance the core social deficits of ASD. Based upon findings describing the neurobiology of ASD combined with our preliminary results, we believe the novel drug acamprosate will show evidence of reducing social skills deficits associated with ASD.

Key facts

Study ID

NCT01813318

Run by

Children's Hospital Medical Center, Cincinnati

People needed

36

Starts

2013-07-02

Expected to finish

2017-09-07

Last updated by the study team

2021-02-03

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Potential subjects with a creatinine clearance < 50 mL/min or evidence of a previous trial of acamprosate will be excluded

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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