Study of Acamprosate in Autism

Autistic Disorder Clinical Trial

Official title:

Double-Blind Placebo-Controlled Study of Acamprosate in Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813318
• Other study ID #: CIN001-Acamprosate in Autism
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2013
• Est. completion date: September 7, 2017

Study information

• Verified date: March 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 7, 2017
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

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.
• Placebo
Subjects receiving placebo will be dosed similarly to the acamprosate group.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Autism Speaks

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 10 on the Social WIthdrawal subscale of ABC	The subscales of the ABC including the Social Withdrawal subscale have proven to be reliable measure of symptoms and behaviors associated with ASD. Specifically, the ABC-SW has been validated as a measure of social impairment that differentiates the social behavior of persons with ASD from those developmental delay without a comorbid ASD diagnosis.	Week 10
Primary	Change Clinical Global Impression- Improvement	The CGI-I is a 7-point scale designed to measure symptomatic change at a specific time as compared to baseline. The CGI-I will be focused on the target symptoms of social impairment.	Week 10
Secondary	Change in ABC subscales: Irritability, Stereotypy, Hyperactivity, and Inappropriate Speech from baseline to week 10	The subscales of the ABC including the Social Withdrawal subscale have proven to be reliable measure of symptoms and behaviors associated with ASD.	Week 10