NCT01592773

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

An Open-Label Extension 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: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 747 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

Detailed description

This clinical study was a 48-week, multicenter, multinational, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at 106 study centers. Patients were eligible for this long-term extension study if they had: * completed the open-label Study MEM MD 67,or * completed the open-label Study MEM-MD-91, or * completed the double-blind Study MEM-MD-68, or * discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response 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 The decision to close the study early was based on data from 2 double-blind placebo-controlled studies (MEM-MD-57A and MEM-MD-68) that failed to demonstrate a statistically significant difference between memantine and placebo in the primary efficacy parameter based on Social Responsiveness Scale (SRS) total raw score.

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)	During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily. During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-01-01
• Completion: 2014-03-01
• First posted: 2012-05-07
• Last updated: 2015-02-16
• Results posted: 2015-02-16

Locations

106 sites across 16 countries: United States, Belgium, Canada, Colombia, Estonia, France, Hungary, Iceland, Italy, New Zealand, Poland, Serbia, South Africa, South Korea, Spain, Ukraine