CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 479 enrolled
Drug / intervention
Memantine Hydrochloride (HCl) +2 moredrug
Likely dose
Memantine Hydrochloride (HCl) 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01592747
NCT01592747Phase 2Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine

Forest Laboratories·interventional·Posted May 7, 2012·Updated Apr 24, 2019

In Brief

A Phase 2 clinical trial evaluating Memantine Hydrochloride (HCl) and Placebo capsules for Autistic Disorder and 5 related conditions. Completed, enrolled 479 participants across 94 sites in 15 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome, Autism Spectrum Disorders, Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
CountriesBelgium, Colombia, Estonia, France, Hungary, Iceland, Italy, New Zealand, Poland, Serbia, South Africa, South Korea, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2012
Enrollment StartSep 1, 2012
Primary CompletionSep 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.2 years ago

Interventions

Memantine Hydrochloride (HCl)drug

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

Memantine Hydrochloride (HCl)drug

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

Placebo capsulesdrug

Once daily, oral administration.