Open-label Study of Safety and Tolerability of Memantine in Children With Autism
Status and phase
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About
The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.
Full 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
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
102 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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