Autism Clinical Trial
Official title:
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
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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