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NCT01813318 · ClinicalTrials.gov registry record · Phase 1
Study of Acamprosate in Autism
A Phase 1 study of Autistic Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01813318: Completed Phase 1 study of Autistic Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01813318 is a Phase 1 study of Autistic Disorder that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 36 participants, below the 112-participant average among 27 other Autistic Disorder trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01813318, a Phase 1 study of Autistic Disorder, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acamprosate
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-07-02 |
| Est. Completion | 2017-09-07 |
| Phase | Phase 1 |
What the finished NCT01813318 record still lists
NCT01813318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 112-participant average among 27 other Autistic Disorder trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Autistic Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01813318 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01813318 about?
NCT01813318 is a clinical study titled "Study of Acamprosate in Autism". 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...
What is the current status of trial NCT01813318?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-07-02. Estimated completion is 2017-09-07.
What conditions does trial NCT01813318 study?
This clinical trial studies the following conditions: Autistic Disorder.
What interventions are being tested in trial NCT01813318?
The interventions under investigation include: Placebo (DRUG), Acamprosate (DRUG).
Who is sponsoring clinical trial NCT01813318?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01813318 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autistic Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01813318's enrollment target sits among peer trials
36 23rd of 27 higher than 5 of 27 other Autistic Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autistic Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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-
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