drugset / Trial / NCT01592786

An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

NCT01592786

Phase 2 Completed 906 enrolled Forest Laboratories
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-06
Primary completion
2013-07
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Memantine Unknown 3 mg Oral
Subject Memantine Unknown 6 mg Oral
Subject Memantine Unknown 9 mg Oral
Subject Memantine Unknown 15 mg Oral

Indications