Study of Acamprosate in Autism

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT01813318

Collaborator

Autism Speaks (Other)

Enrollment

Location

Arms

50.2

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder	Drug: Acamprosate Drug: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Double-Blind Placebo-Controlled Study of Acamprosate in Autism

Actual Study Start Date :

Jul 2, 2013

Actual Primary Completion Date :

Sep 7, 2017

Actual Study Completion Date :

Sep 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo/sugar pill Placebo will be dosed similar to acamprosate, in terms of dosage form, frequency and duration.	Drug: Placebo Subjects receiving placebo will be dosed similarly to the acamprosate group.
Active Comparator: Acamprosate 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. Other Name: Campral	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. Other Names: Campral

Arm

Intervention/Treatment

Placebo Comparator: Placebo/sugar pill

Placebo will be dosed similar to acamprosate, in terms of dosage form, frequency and duration.

Drug: Placebo

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

Active Comparator: Acamprosate

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. Other Name: Campral

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.

Other Names:

Campral

Outcome Measures

Primary Outcome Measures

Change from baseline to week 10 on the Social WIthdrawal subscale of ABC [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. 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.
Change Clinical Global Impression- Improvement [Week 10]
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.

Secondary Outcome Measures

Change in ABC subscales: Irritability, Stereotypy, Hyperactivity, and Inappropriate Speech from baseline to week 10 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati
Autism Speaks

Investigators

Principal Investigator: Craig A Erickson, M.D., Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT01813318

Other Study ID Numbers:

CIN001-Acamprosate in Autism

First Posted:

Mar 18, 2013

Last Update Posted:

Feb 3, 2021

Last Verified:

Mar 1, 2020

Additional relevant MeSH terms:

Autistic Disorder

Acamprosate

Study Results

No Results Posted as of Feb 3, 2021