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