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An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

NCT01592786 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 906

Last updated 2014-08-07

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

Conditions

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

Interventions

DRUG

Memantine Hydrochloride (HCl)

Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.

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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-07-31
Completion
2013-08-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Colombia
  • Estonia
  • France
  • Hungary
  • Iceland
  • Italy
  • New Zealand
  • Poland
  • Serbia
  • Singapore
  • 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 NCT01592786 on ClinicalTrials.gov