CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 906 enrolled
Drug / intervention
Memantine Hydrochloride (HCl)drug
Likely dose
Memantine Hydrochloride (HCl) 15 mgfrom 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/NCT01592786
NCT01592786Phase 2Completed
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An Open-Label Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Forest Laboratories·interventional·Posted May 7, 2012·Updated Aug 7, 2014

In Brief

A Phase 2 clinical trial evaluating Memantine Hydrochloride (HCl) for Autism Spectrum Disorder (ASD) and 6 related conditions. Completed, enrolled 906 participants across 118 sites in 18 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder (ASD), Autism, Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
CountriesAustralia, Belgium, Canada, Colombia, Estonia, France, Hungary, Iceland, Italy, New Zealand, Poland, Serbia, Singapore, South Africa, South Korea, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2012
Enrollment StartJun 1, 2012
Primary CompletionJul 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.2 years ago

Interventions

Memantine Hydrochloride (HCl)drug

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.