Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism - Full Text View

Purpose

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

Condition	Intervention	Phase
Autism	Drug: Memantine-HCl Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	An Open-label (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism

Resource links provided by NLM:

MedlinePlus related topics: Autism

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Change in Social Responsiveness Scale [ Time Frame: Baseline, 6 weeks after baseline, end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Core Autism Treatment Scale-Improvement and Children's Communication Checklist. [ Time Frame: Baseline and every 2 weeks to end of treatment ] [ Designated as safety issue: No ]

Enrollment:	121
Study Start Date:	April 2009
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Once daily oral administration of memantine for 12 weeks.	Drug: Memantine-HCl Memantine - 3mg and 6mg capsules at a dosage of 3, 6, 9, 12, 15 or 18 mg/d (depending on weight) administered orally. Other Name: Namenda (TM)
Placebo Comparator: 2 Once daily oral administration of placebo for 12 weeks.	Drug: Placebo Placebo capsules, once daily, oral administration.

Detailed Description:

This is a multicenter, two-part study in pediatric (ages 6 to 12 years) patients diagnosed with autism.

Patients participating In Part One will receive a single open-label dose of memantine HCl. 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.

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females ages 6 to 12 years
Diagnosis of autistic disorder,
A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient,

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872898

Locations

United States, Arizona
Forest Investigative Site
Phoenix, Arizona, United States, 85006
United States, California
Forest Investigative Site
Sacramento, California, United States, 95817
Forest Investigative Site
San Francisco, California, United States, 94143
Forest Investigative Site
Santa Ana, California, United States, 92705
Forest Investigative Site
Stanford, California, United States, 94305
United States, Florida
Forest Investigative Site
Jacksonville Beach, Florida, United States, 32250
Forest Investigative Site
St Petersburg, Florida, United States, 33701
United States, Illinois
Forest Investigative Site
Chicago, Illinois, United States, 60608
Forest Investigative Site
Hoffman Estates, Illinois, United States, 60169
Forest Investigative site
Naperville, Illinois, United States, 60563
United States, Indiana
Forest Investigative Site
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Forest Investigative Site
Cambridge, Massachusetts, United States, 02138
United States, New Jersey
Forest Investigative Site
Toms River, New Jersey, United States, 08755
Forest Investigative Site
Voorhees, New Jersey, United States, 08043
United States, New York
Forest Investigative Site
Manhasset, New York, United States, 11030
United States, Ohio
Forest Investigative Site
Cleveland, Ohio, United States, 44106
Forest Investigative Site
Clevland, Ohio, United States, 44106
Forest Investigative Site
Columbus, Ohio, United States, 43210
United States, Oklahoma
Forest Investigative
Enid, Oklahoma, United States, 73707
Forest Investigative Site
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
Forest Investigative Site
Pittsburgh, Pennsylvania, United States, 15203

Sponsors and Collaborators

Forest Laboratories

Merz Pharmaceuticals GmbH

Investigators

Study Director:

Ephraim Katz, PhD

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

More Information

No publications provided

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00872898 History of Changes
Other Study ID Numbers:	MEM-MD-57A
Study First Received:	March 30, 2009
Last Updated:	August 16, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

autism
memantine
pediatric
Forest Laboratories
Autism in pediatric patients

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 May 22, 2013