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

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

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

Inclusion Criteria:

• Completed lead-in study MEM-MD-57A (NCT00872898)
• A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient

Exclusion Criteria:

• Patients with a concurrent medical condition that might interfere with the conduct of the study