At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 124 enrolled
Drug / intervention
Memantine - Extended Release (ER) +1 moredrug
Likely dose
Memantine - Extended Release (ER) 3mgfrom 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 (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism
In Brief
A Phase 2 clinical trial evaluating Memantine - Extended Release (ER) and Placebo for Autism. Completed, enrolled 124 participants across 17 sites.
Detailed Summary
The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
CollaboratorsMerz Pharmaceuticals GmbH
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartApr 2009
Primary CompletionAug 2012
TodayJul 2026
First PostedMar 31, 2009
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.3 years ago
Interventions
Memantine - Extended Release (ER)drug
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
Placebodrug
Placebo capsules, once daily, oral administration.