Study of Acamprosate in Autism
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|ClinicalTrials.gov Identifier: NCT01813318|
Recruitment Status : Active, not recruiting
First Posted : March 18, 2013
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder||Drug: Acamprosate Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Placebo/sugar pill
Placebo will be dosed similar to acamprosate, in terms of dosage form, frequency and duration.
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
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
- 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.
- 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.
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
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Craig A Erickson, M.D.||Children's Hospital Medical Center, Cincinnati|