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)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 906 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks). Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score. Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats. The weight-based dose limits in this study were as follows: * Group A: ≥ 60 kg; maximum 15 mg/day * Group B: 40-59 kg; maximum 9 mg/day * Group C: 20-39 kg; maximum 6 mg/day * Group D: \< 20 kg; maximum 3 mg/day

Conditions

• Autism Spectrum Disorder (ASD)
• Autism
• Autistic Disorder
• Asperger's Disorder
• Asperger's
• Pediatric Autism
• Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Interventions

Type	Name	Description
DRUG	Memantine Hydrochloride (HCl)	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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2012-05-07
• Last updated: 2014-08-07
• Results posted: 2014-08-07

Locations

118 sites across 18 countries: United States, Australia, Belgium, Canada, Colombia, Estonia, France, Hungary, Iceland, Italy, New Zealand, Poland, Serbia, Singapore, South Africa, South Korea, Spain, Ukraine