NCT01813318

Study of Acamprosate in Autism

Double-Blind Placebo-Controlled Study of Acamprosate in Autism

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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 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.

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 acamprosate as part of the study procedures for 16 weeks.

Conditions

• Autistic Disorder

Interventions

Type	Name	Description
DRUG	Acamprosate	The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 50kg and 1332 mg per day for those less weighing less than 50kg.
DRUG	Placebo	Subjects receiving placebo will be dosed similarly to the acamprosate group.

Timeline

• Start date: 2013-07-02
• Primary completion: 2017-09-07
• Completion: 2017-09-07
• First posted: 2013-03-18
• Last updated: 2021-02-03

Locations

1 site across 1 country: United States