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Trial of Memantine for Cognitive Impairment in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00300716
Recruitment Status : Unknown
Verified April 2007 by Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : March 9, 2006
Last Update Posted : August 28, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Cognition Disorders Drug: Memantine Phase 2 Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple Sclerosis
Study Start Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Controlled Oral Word Association Test
  2. Stroop Color and Word Test
  3. Symbol Digit Modalities Test
  4. Delis-Kaplan Executive Function System
  5. Perceived Deficit Questionnaire
  6. Multiple Sclerosis Screening Neuropsychological Questionnaire
  7. Modified Neuropsychiatric Inventory
  8. Fatigue Severity Scale
  9. Modified Fatigue Impact Scale
  10. MS Quality of Life Inventory
  11. Beck Depression Inventory

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

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): NCT00300716

Contact: Lillian Nguyen, BS 503-494-7240 nguyelil@ohsu.edu

United States, California
USC Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Dan Bandari, MD         
United States, Oregon
OHSU Completed
Portland, Oregon, United States, 97201
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390-9036
Principal Investigator: Elliot Frohman, MD         
United States, Washington
MS Hub Recruiting
Seattle, Washington, United States, 98101
Principal Investigator: Ted Brown, MD         
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00300716     History of Changes
Other Study ID Numbers: NAM-MD-13
First Posted: March 9, 2006    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: April 2007

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

Additional relevant MeSH terms:
Multiple Sclerosis
Cognitive Dysfunction
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