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Memantine in Pediatric Autism
NCT00872898Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2009
- Primary completion
- Aug 2012
- Countries
- 1
- Sponsor
- Forest Laboratories
- Modality
- Small Molecules
- Drugs
- memantine
- Conditions
- Autism Spectrum Disorder (ASD)
01
Overview
Phase 2, randomised, double-blind trial in Autism Spectrum Disorder (ASD) comparing Memantine ER with Placebo (2 arms). Primary endpoints: Extent of Absorption of Memantine (Part One) at 144 hours and Change in Total Raw Score of Social Responsiveness Scale at 12 weeks. Started Apr 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Memantine ER
Memantine Extended Release (3-18 mg/day based on weight)
Placebo
Placebo capsules
03
Who it enrols
Pediatric patients (6-12 years generally, up to 18 if completed prior study) with a diagnosis of autistic disorder.
04
Endpoints
Primary
Extent of Absorption of Memantine (Part One)
Change in Total Raw Score of Social Responsiveness Scale
Secondary
Core Autism Treatment Scale-Improvement: Total Score
Core Autism Treatment Scale-Improvement: Social Interaction
Core Autism Treatment Scale-Improvement: Communication
Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale
Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale
Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale
Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale
Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale
05
Results
Not all primary endpoints met
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