Study of Acamprosate in Autism

NCT01813318 | Completed Phase 1 DMC

• 1 other identifier: CIN001-Acamprosate in Autism
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  Week 10

Study Arms (2)

Placebo/sugar pill

PLACEBO COMPARATOR

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

Drug: Placebo

Acamprosate

ACTIVE COMPARATOR

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

Interventions

Acamprosate DRUG

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.

Also known as: Campral

Acamprosate

Placebo DRUG

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

Placebo/sugar pill

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Autism Speaks: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Craig A Erickson, M.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: March 18, 2013
• Study Start: July 2, 2013
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: February 3, 2021

Record last verified: 2020-03

Locations

US (1)