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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Acamprosate

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2013-07-02
Est. Completion 2017-09-07
Phase Phase 1

What the Registry Record Tells You About NCT01813318

The ClinicalTrials.gov registry entry for NCT01813318 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 112-participant average among 27 other Autistic Disorder trials with a reported enrollment target (68% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.