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Memantine in Adult Autism Spectrum Disorder

This study has been terminated.
(Sponsor withdrew funds)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01078844
First Posted: March 2, 2010
Last Update Posted: July 26, 2017
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.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Johns Hopkins University
  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 not otherwise specified (NOS).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Enrollment: 4
Actual Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (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

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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)
  • Participant has a diagnosis of:

    • Autistic Disorder
    • Asperger's Disorder
    • Pervasive Developmental 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
  • Glomerular Filtration Rate (GFR) < 30 mL/min
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01078844     History of Changes
Other Study ID Numbers: NA_00015760
First Submitted: March 1, 2010
First Posted: March 2, 2010
Results First Submitted: May 17, 2017
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Asperger Syndrome
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Memantine
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