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

This study has been completed.
Sponsor:
Collaborator:
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01999894
First received: November 26, 2013
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Autism
Pediatric Autism
Drug: Memantine HCl
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    Number of patients who experienced one or more TEAEs during the study


Enrollment: 102
Study Start Date: November 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999894

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

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01999894     History of Changes
Other Study ID Numbers: MEM-MD-67
Study First Received: November 26, 2013
Results First Received: January 31, 2014
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Namenda
Autism
Memantine
Pediatric
Forest Laboratories

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014