NCT01999894

Open-label Study of Safety and Tolerability of Memantine in Children With Autism

An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.

Detailed description

This is a 48-week multicenter extension study comprised of a 6-week double-blind dose-titration period followed by a 42-week open-label maintenance period. In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats. The weight-based dose limits in these studies were as follows: * Group A: ≥ 60 kg; max 15 mg/day * Group B: 40-59 kg; max 9 mg/day * Group C: 20-39 kg; max 6 mg/day * Group D: \< 20 kg; max 3 mg/day

Conditions

• Autism
• Pediatric Autism

Interventions

Type	Name	Description
DRUG	Memantine HCl	Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-12-03
• Last updated: 2014-03-18
• Results posted: 2014-03-18

Locations

19 sites across 1 country: United States