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Study of Acamprosate in Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01813318
Recruitment Status : Active, not recruiting
First Posted : March 18, 2013
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Placebo-Controlled Study of Acamprosate in Autism
Study Start Date : April 2013
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


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 Name: Campral




Primary Outcome Measures :
  1. Change from baseline to week 10 on the Social WIthdrawal subscale of ABC [ Time Frame: 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.

  2. Change Clinical Global Impression- Improvement [ Time Frame: 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 :
  1. Change in ABC subscales: Irritability, Stereotypy, Hyperactivity, and Inappropriate Speech from baseline to week 10 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813318


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Autism Speaks
Investigators
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Principal Investigator: Craig A Erickson, M.D. Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01813318    
Other Study ID Numbers: CIN001-Acamprosate in Autism
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Acamprosate
Alcohol Deterrents