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: July 15, 2014
Last verified: July 2014
  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 responders for participation in a 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)
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:
  • Number of Confirmed Social Responsiveness Scale (SRS) Responders [ Time Frame: Visit 1 (Baseline) to Visit 8 (week 48/Final Visit) ] [ Designated as safety issue: No ]

    A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks.

    The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment.



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)
Once daily oral administration of open-label memantine for up to 48 weeks: 6-week dose-titration period followed by up to 42-week maintenance period.
Drug: Memantine Hydrochloride (HCl)
Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.
Other Name: Namenda

Detailed Description:

This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks).

Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in this study were as follows:

  • Group A: ≥ 60 kg; maximum 15 mg/day
  • Group B: 40-59 kg; maximum 9 mg/day
  • Group C: 20-39 kg; maximum 6 mg/day
  • Group D: < 20 kg; maximum 3 mg/day
  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
Results First Received: July 15, 2014
Last Updated: July 15, 2014
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
Pediatric Disorder

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

ClinicalTrials.gov processed this record on September 18, 2014