Memantine in Adult Autism Spectrum Disorder

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01078844
First received: March 1, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder NOS.


Condition Intervention
Autism
Asperger's Disorder
Pervasive Developmental Disorder NOS
Drug: memantine
Drug: Placebo

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: Memantine in Adult Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Clinical Global Impression-Scale(CGI-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Treatment as usual plus placebo
Drug: Placebo
Look-alike placebo
Active Comparator: memantine
Treatment as usual plus memantine
Drug: memantine
memantine 5-20 mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Participant is currently in treatment in the JHBMC ASNC
  • Participant has a diagnosis of:
  • Autistic Disorder
  • Asperger's Disorder
  • PDD NOS
  • Participant meets one of the following criteria:
  • CGI-S >= 4 (CGI-S: ________)
  • Participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine:

    1. _____________________________________________
    2. _____________________________________________
    3. _____________________________________________

Exclusion criteria

The patient meets none of the following criteria (mark if absent):

  • Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible).
  • Rett's Syndrome or Childhood Disintegrative Disorder
  • Active treatment with an acetylcholinesterase inhibitor
  • Prior or current treatment with memantine
  • Current treatment with lamotrigine
  • Genetic, metabolic or degenerative disorder (excepting Fragile X).
  • Brain malformation or known severe brain trauma
  • Pregnancy or breastfeeding
  • GFR < 30 mL/min
  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: NCT01078844

Locations
United States, Maryland
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Forest Laboratories
Investigators
Principal Investigator: Eric Samstad, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Eric Samstad, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01078844     History of Changes
Other Study ID Numbers: NAM_MD_69
Study First Received: March 1, 2010
Last Updated: March 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Autism
Asperger's Disorder
Pervasive Developmental Disorder NOS
Adult
Memantine

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