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Trial of Memantine for Cognitive Impairment in Multiple Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Oregon Health and Science University.
Recruitment status was:  Recruiting
Forest Laboratories
University of Southern California
University of Texas Southwestern Medical Center
MS-Hub Seattle
Information provided by:
Oregon Health and Science University Identifier:
First received: March 8, 2006
Last updated: August 27, 2009
Last verified: April 2007
This study is designed to determine whether memantine is an effective treatment for memory and cognitive problems associated with multiple sclerosis when compared to placebo.

Condition Intervention Phase
Multiple Sclerosis
Cognition Disorders
Drug: Memantine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.

Secondary Outcome Measures:
  • Controlled Oral Word Association Test
  • Stroop Color and Word Test
  • Symbol Digit Modalities Test
  • Delis-Kaplan Executive Function System
  • Perceived Deficit Questionnaire
  • Multiple Sclerosis Screening Neuropsychological Questionnaire
  • Modified Neuropsychiatric Inventory
  • Fatigue Severity Scale
  • Modified Fatigue Impact Scale
  • MS Quality of Life Inventory
  • Beck Depression Inventory

Estimated Enrollment: 146
Study Start Date: April 2004
  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. A diagnosis of multiple sclerosis as defined by the McDonald criteria. Patients with relapsing-remitting, secondary progressive, and primary progressive forms of MS are eligible.
  2. Age between 18 and 65 years.
  3. Demonstrated cognitive dysfunction at screening defined as a score worse than 1.0 standard deviations below the mean on the PASAT or the CVLT-II.

Exclusion Criteria:

  1. A history of major depression, psychosis, or a score > 19 on the Beck's Depression Inventory.
  2. Corrected binocular visual acuity worse than 20/50; any impairment of binocular color vision.
  3. Patients that do not speak English as a primary language (fluency may impact performance).
  4. A clinically significant MS exacerbation within 30 days of the screening
  5. Pregnancy
  6. Renal insufficiency.
  7. History of seizures.
  8. Patients using acetazolamide (Diamox, Ak-sol, Storzolamide), dichlorphenamide (Daranide), methazolamide (Neptazane) or topiramate (Topamax), dextromethorphan (Robitussin DM and other cold remedies), or amantadine (Symmetrel).
  9. Use of medical marijuana in the prior six months.
  10. History of alcohol abuse or illicit drug use in the prior six 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 identifier: NCT00300716

United States, California
Los Angeles, California, United States, 90033
United States, Oregon
Portland, Oregon, United States, 97201
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390-9036
United States, Washington
MS Hub
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Oregon Health and Science University
Forest Laboratories
University of Southern California
University of Texas Southwestern Medical Center
MS-Hub Seattle
Principal Investigator: Dennis Bourdette, MD Oregon Health and Science University
Principal Investigator: Lovera Jesus, MD Oregon Health and Science University
Principal Investigator: Daniel Bandari, MD University of Southern California
Principal Investigator: Ted Brown, MD MS Hub
Principal Investigator: Elliot Frohman, MD UT Southwestern
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00300716     History of Changes
Other Study ID Numbers: NAM-MD-13 
Study First Received: March 8, 2006
Last Updated: August 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Multiple Sclerosis
Cognitive impairment
Neuropsychological tests
Quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Cognition Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurocognitive Disorders
Mental Disorders
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 processed this record on January 17, 2017