Conditions: Autistic Disorder Autism Asperger's Disorder Asperger Syndrome Autism Spectrum Disorders Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
Keywords: Asperger's Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Memantine Pediatric Disorder Randomized Controlled Trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 479
Healthy volunteers: no

Brief summary:
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

Detailed description:
This clinical study was a 12-week, multicenter, double-blind, placebo-controlled, randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). Patients who completed at least 12 weeks of study drug exposure and met protocol specified responder criterion in lead in Study MEM-MD-91 (NCT01592786) at two consecutive visits separated by at least two weeks were eligible to transition to this study. The responder criterion was defined as having at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score in Study MEM-MD-91.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents 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 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

Arms:
arm 1: Patients randomized to the full dose arm will continue taking memantine at the same tolerability and weight-based dose achieved in lead-in Study MEM-MD-91. Dosing will be once daily for up to 12 weeks. arm 2: Patients randomized to the reduced dose arm will take memantine at the tolerability and weight based dose that they received in lead in Study MEM-MD-91 reduced by at least 50%. Dosing will be once daily for up to 12 weeks. arm 3: Dosing will be once daily for up to 12 weeks.

Interventions: intervention 1: Memantine Hydrochloride (HCl) intervention 2: Memantine Hydrochloride (HCl) intervention 3: Placebo capsules
Intervention descriptions: intervention 1: Extended Release Dose ranging from 3-15mg/day; administered orally intervention 2: Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally. intervention 3: Once daily, oral administration.

Protocol document: