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NCT01592747 · ClinicalTrials.gov registry record · Phase 2
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
A Phase 2 study of Autism and Autistic Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 479
- Enrollment target
- 20
- Study locations
NCT01592747 is a Phase 2 study of Autism and Autistic Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 479 participants, above the 179-participant average among 104 other Autism trials with a reported enrollment target (168% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT01592747, a Phase 2 study of Autism and Autistic Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 479 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
Conditions Studied
Interventions
- DRUG Placebo capsules
- DRUG Memantine Hydrochloride (HCl)
Study Locations (20)
Florida
- Forest Investigative Site 075 - Bradenton
- Forest Investigative Site 080 - Gainesville
- Forest Investigative Site 117 - Jacksonville
- Forest Investigative Site 065 - Maitland
- Forest Investigative Site 118 - Miami
- Forest Investigative Site 085 - Oakland Park
- Forest Investigative Site 115 - Orange City
California
- Forest Investigative Site 054 - Glendale
- Forest Investigative Site 109 - Imperial
- Forest Investigative Site 096 - Los Angeles
- Forest Investigative Site 021 - San Francisco
- Forest Investigative Site 026 - Santa Ana
- Forest Investigative Site 002 - Stanford
Arizona
- Forest Investigative Site 005 - Phoenix
- Forest Investigative Site 055 - Tucson
Colorado
- Forest Investigative Site 078 - Boulder
- Forest Investigative Site 073 - Centennial
Alabama
- Forest Investigative Site 068 - Dothan
Arkansas
- Forest Investigative Site 077 - Little Rock
District of Columbia
- Forest Investigative Site 052 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01592747
The ClinicalTrials.gov registry entry for NCT01592747 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 479 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 179-participant average among 104 other Autism trials with a reported enrollment target (168% higher). The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Autism appearing as the primary indexed condition, and to 2 interventions - of which Placebo capsules is the first listed.
NCT01592747 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01592747 about?
NCT01592747 is a clinical study titled "Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine". The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
What is the current status of trial NCT01592747?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 479 participants. The study started on 2012-09. Estimated completion is 2013-10.
What conditions does trial NCT01592747 study?
This clinical trial studies the following conditions: Autism, Autistic Disorder, Autism Spectrum Disorders, Asperger Syndrome, Asperger's Disorder.
What interventions are being tested in trial NCT01592747?
The interventions under investigation include: Placebo capsules (DRUG), Memantine Hydrochloride (HCl) (DRUG).
Who is sponsoring clinical trial NCT01592747?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01592747 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.