Open-label Study of Safety and Tolerability of Memantine in Children With Autism

The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Pediatric Autism

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Forest Investigative Site 005, Phoenix, Arizona, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

memantine HCl

Drug

Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.

Other names: Namenda, Namenda XR

Primary outcomes

Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)

Time frame: From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)

Number of patients who experienced one or more TEAEs during the study

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

Merz Pharmaceuticals GmbH

Registry information

Official study title

An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Dec 3, 2013
Registry last updated: Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed