Back to resultsStudy of Acamprosate in Autism
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acamprosate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Autistic Disorder
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo/sugar pill
Acamprosate
Arm Description
Placebo will be dosed similar to acamprosate, in terms of dosage form, frequency and duration.
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01813318
First Posted
January 30, 2013
Last Updated
February 1, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Autism Speaks
1. Study Identification
Unique Protocol Identification Number
NCT01813318
Brief Title
Study of Acamprosate in Autism
Official Title
Double-Blind Placebo-Controlled Study of Acamprosate in Autism
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2013 (Actual)
Primary Completion Date
September 7, 2017 (Actual)
Study Completion Date
September 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Autism Speaks
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo/sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo will be dosed similar to acamprosate, in terms of dosage form, frequency and duration.
Arm Title
Acamprosate
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Acamprosate
Other Intervention Name(s)
Campral
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects receiving placebo will be dosed similarly to the acamprosate group.
Primary Outcome Measure Information:
Title
Change from baseline to week 10 on the Social WIthdrawal subscale of ABC
Description
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.
Time Frame
Week 10
Title
Change Clinical Global Impression- Improvement
Description
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.
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Change in ABC subscales: Irritability, Stereotypy, Hyperactivity, and Inappropriate Speech from baseline to week 10
Description
The subscales of the ABC including the Social Withdrawal subscale have proven to be reliable measure of symptoms and behaviors associated with ASD.
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig A Erickson, M.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
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Study of Acamprosate in Autism
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