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

NCT01592773 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 747

Last updated 2015-02-16

Study results available
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Summary

The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

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)

During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily. During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.

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
2012-10-31
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • United States
  • Belgium
  • Canada
  • 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 NCT01592773 on ClinicalTrials.gov