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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: Completed Phase 2 study of Autism and Autistic Disorder, sponsored by Forest Laboratories.

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Loss of Therapeutic response is defined as a worsening (increase) of at least 10 points in Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 (randomization) score. The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment with total raw score ranging from 0 (no impairment) to 195 (severe social impairment). Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms)

Conditions Studied

Autism Autistic Disorder Autism Spectrum Disorders Asperger Syndrome Asperger's Disorder Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)

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

FieldValue
Enrollment Target 479 participants
Start Date 2012-09
Est. Completion 2013-10
Phase Phase 2
Forest Laboratories

145 total trials

What the finished NCT01592747 record still lists

NCT01592747 is an interventional study that assigns participants to a tested intervention. The registered 479 participants enrollment target is mid-sized for trials with a published cap, above the 179-participant average among 104 other Autism trials with a reported enrollment target (168% higher).

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 names 20 study sites across 7 states, led by 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.

Learn More About Clinical Trials

Similar trials for Autism

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 NCT01592747's enrollment target sits among peer trials

479 7th of 104 higher than 98 of 104 other Autism trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autism 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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Related registry views

Source: ClinicalTrials.gov NCT01592747, the US trial registry maintained by the National Library of Medicine. NCT01592747 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.