Conditions: Autism Spectrum Disorder (ASD) Autism Autistic Disorder Asperger's Disorder Asperger's Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Keywords: Autistic Disorder Asperger's Disorder Asperger's Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Pervasive Child Development Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 747
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: To maintain the blind of the preceding study, patients who participated in MEM-MD-68 (NCT01592747) began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.

Patients who took open-label memantine in study MEM-MD-67 (NCT01999894) or MEM-MD-91(NCT01592786), received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.

Interventions: intervention 1: Memantine Hydrochloride (HCl)
Intervention descriptions: intervention 1: During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily.

During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.

Protocol document: