An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01592786
First received: May 3, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify eligible patients for participation in the follow-up randomized withdrawal study.


Condition Intervention Phase
Autism Spectrum Disorder (ASD)
Autism
Autistic Disorder
Asperger's Disorder
Asperger's
Pediatric Autism
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Pervasive Child Development Disorder
Drug: Memantine Hydrochloride (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 Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Safety [ Time Frame: 50 weeks ] [ Designated as safety issue: Yes ]
    Adverse event (AE) monitoring, clinical laboratory measures, vital sign parameters, electrocardiograms (ECGs), suicidality, and physical examinations.


Enrollment: 906
Study Start Date: June 2012
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine Hydrochloride (HCl)
This 50-week multicenter clinical study is comprised of a 2-week screening period, a 6-week open label dose-titration period followed up by a 42-week open-label maintenance period.
Drug: Memantine Hydrochloride (HCl)
Up to 50 weeks, multicenter, open-label study, Memantine extended-release 3-mg capsules, oral administration. Dosing will be weight based.
Other Name: Namenda

Detailed Description:

This 50-week multicenter clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by up to 42-week open-label maintenance period.

Approximately 900 pediatric patients (aged 6-12 years) may enter this study at approximately 180 study centers. Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion will be eligible to transition to a randomized withdrawal study.

  Eligibility

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

Inclusion Criteria:

  1. Male or female outpatients.
  2. Age of 6-12.
  3. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
  4. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study

Exclusion Criteria:

  1. Have enrolled in Study MEM-MD-57A
  2. Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being.
  3. Participation in any other clinical investigation using an experimental drug within 30 days of screening.
  4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS.
  5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months
  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: NCT01592786

  Show 118 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Jordan Lateiner, MS, MBA Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01592786     History of Changes
Other Study ID Numbers: MEM-MD-91
Study First Received: May 3, 2012
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Public Health Agency of Canada
Colombia: Ministry of Health and Social Protection
Estonia: The State Agency of Medicine
France: Ministry of Health
Hungary: Research Ethics Medical Committee
Iceland: Ministry of Health and Social Security
Italy: Ethics Committee
New Zealand: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Ministry of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Ukraine: Ministry of Health

Keywords provided by Forest Laboratories:
Autism Spectrum Disorder (ASD)
Autism
Autistic Disorder
Asperger's Disorder
Asperger's
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Memantine
Pervasive Child Development Disorder
Pediatric Disorder

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Asperger Syndrome
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