At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 enrolled
Drug / intervention
Memantine HCldrug
Likely dose
Memantine HCl 18 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.
An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism
In Brief
A Phase 2 clinical trial evaluating Memantine HCl for Autism and Pediatric Autism. Completed, enrolled 102 participants across 19 sites.
Detailed Summary
The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism, Pediatric Autism
CountriesUnited States
CollaboratorsMerz Pharmaceuticals GmbH
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
Primary CompletionFeb 2013
First PostedDec 2013
TodayJul 2026
First PostedDec 3, 2013
Enrollment StartNov 1, 2009
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.6 years ago
Interventions
Memantine HCldrug
Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.