Working... Menu
Trial record 33 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01999894
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Autism Pediatric Autism Drug: Memantine HCl Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism
Study Start Date : November 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01999894

Layout table for location information
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 026
Santa Ana, California, United States, 92701
Forest Investigative Site 020
Santa Ana, California, United States, 92705
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
Layout table for investigator information
Study Director: Ephraim Katz, PhD Forest Laboratories

Layout table for additonal information
Responsible Party: Forest Laboratories Identifier: NCT01999894     History of Changes
Other Study ID Numbers: MEM-MD-67
First Posted: December 3, 2013    Key Record Dates
Results First Posted: March 18, 2014
Last Update Posted: March 18, 2014
Last Verified: January 2014

Keywords provided by Forest Laboratories:
Forest Laboratories

Additional relevant MeSH terms:
Layout table for MeSH terms
Child Development Disorders, Pervasive
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents