Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism

Forest Laboratories

Status and phase

Completed

Phase 2

Conditions

Autism

Treatments

Drug: Placebo

Drug: Memantine - Extended Release (ER)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00872898

MEM-MD-57A

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

Full description

This is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed with autism.

Patients participating in Part One will receive a single open-label dose of memantine. Blood samples for pharmacokinetic analysis will be collected.

Part Two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study evaluating change in all core domains (social interactions, communication, and restricted interests and repetitive behaviors) of autism.

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

124 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males or females ages 6 to 12 years
Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 & 3).
A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
Patients over age 12, only if they completed Study MEM-PK-21

Exclusion criteria

Medical history of active epilepsy/seizure disorder except simple febrile seizures
Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study