Study of Acamprosate in Autism
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 2/13/2019 |
| Start Date: | April 2013 |
| End Date: | March 2020 |
Double-Blind Placebo-Controlled Study of Acamprosate in Autism
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.
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.
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 acamprosate as part of the study procedures for 16 weeks.
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:
- 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 Criteria:
- Potential subjects with a creatinine clearance < 50 mL/min or evidence of a previous
trial of acamprosate will be excluded
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Craig A Erickson, MD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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