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

January 31, 2014 updated by: Forest Laboratories

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Forest Investigative Site 005
    • California
      • Sacramento, California, United States, 95817
        • Forest Investigative Site 003
      • San Francisco, California, United States, 94143
        • Forest Investigative Site 021
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 026
      • Santa Ana, California, United States, 92705
        • Forest Investigative Site 020
      • Stanford, California, United States, 94305
        • Forest Investigative Site 002
    • Florida
      • Jacksonville Beach, Florida, United States, 32250
        • Forest Investigative Site 024
      • St. Petersburg, Florida, United States, 33701
        • Forest Investigative Site 007
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Forest Investigative Site 014
      • Naperville, Illinois, United States, 60563
        • Forest Investigative Site 023
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Forest Investigative Site 010
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Forest Investigative Site 025
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Forest Investigative Site 011
      • Voorhees, New Jersey, United States, 08043
        • Forest Investigative Site 006
    • New York
      • Manhasset, New York, United States, 10030
        • Forest Investigative Site 017
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Forest Investigative Site 013
      • Cleveland, Ohio, United States, 44106
        • Forest Investigative Site 015
      • Columbus, Ohio, United States, 43210
        • Forest Investigative Site 001
    • Oklahoma
      • Oklahoma, Oklahoma, United States, 73116
        • Forest Investigative Site 019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Memantine
Once daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period.
Drug: Memantine HCl
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

Merz Pharmaceuticals GmbH

Investigators

  • Study Director: Ephraim Katz, PhD, Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (ESTIMATE)

December 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM-MD-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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