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Study of Acamprosate in Autism

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ClinicalTrials.gov Identifier: NCT01813318
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : February 3, 2021
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE January 30, 2013
First Posted Date  ICMJE March 18, 2013
Last Update Posted Date February 3, 2021
Actual Study Start Date  ICMJE July 2, 2013
Actual Primary Completion Date September 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
  • Change from baseline to week 10 on the Social WIthdrawal subscale of ABC [ Time Frame: Week 10 ]
  • Change Clinical Global Impression- Improvement [ Time Frame: Week 10 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
Change in ABC subscales: Irritability, Stereotypy, Hyperactivity, and Inappropriate Speech from baseline to week 10 [ Time Frame: Week 10 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Acamprosate in Autism
Official Title  ICMJE Double-Blind Placebo-Controlled Study of Acamprosate in Autism
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Autistic Disorder
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Subjects receiving placebo will be dosed similarly to the acamprosate group.
Study Arms  ICMJE
  • Placebo Comparator: Placebo/sugar pill
    Placebo will be dosed similar to acamprosate, in terms of dosage form, frequency and duration.
    Intervention: Drug: Placebo
  • 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

    Intervention: Drug: Acamprosate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2013)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 7, 2017
Actual Primary Completion Date September 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01813318
Other Study ID Numbers  ICMJE CIN001-Acamprosate in Autism
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Children's Hospital Medical Center, Cincinnati
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Autism Speaks
Investigators  ICMJE
Principal Investigator: Craig A Erickson, M.D. Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP