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Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine

NCT01592747 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2019-04-24

Study results available
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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

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

Interventions

DRUG

Memantine Hydrochloride (HCl)

Extended Release Dose ranging from 3-15mg/day; administered orally

DRUG

Memantine Hydrochloride (HCl)

Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.

DRUG

Placebo capsules

Once daily, oral administration.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Jordan Lateiner, MS, MBA · Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • United States
  • Belgium
  • Colombia
  • Estonia
  • France
  • Hungary
  • Iceland
  • Italy
  • New Zealand
  • Poland
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01592747 on ClinicalTrials.gov