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Trial of Memantine for Cognitive Impairment in Multiple Sclerosis

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.
 
ClinicalTrials.gov Identifier: NCT00300716
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
Forest Laboratories
University of Southern California
University of Texas Southwestern Medical Center
MS-Hub Seattle
Information provided by (Responsible Party):
Oregon Health and Science University

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 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
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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


Locations
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United States, California
USC
Los Angeles, California, United States, 90033
United States, Oregon
OHSU
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
Investigators
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00300716    
Other Study ID Numbers: NAM-MD-13
First Posted: March 9, 2006    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oregon Health and Science University:
Multiple Sclerosis
Cognitive impairment
Memantine
Placebo
Neuropsychological tests
Quality of life
Fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
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
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