Trial of Memantine for Cognitive Impairment in Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2007 by Oregon Health and Science University. Recruitment status was Recruiting

First Received on March 8, 2006. Last Updated on August 27, 2009 History of Changes

Sponsor:	Oregon Health and Science University
Collaborators:	Forest Laboratories University of Southern California University of Texas Southwestern Medical Center MS-Hub Seattle
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00300716

Purpose

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 II Phase III

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:

MedlinePlus related topics: Fatigue Multiple Sclerosis

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Age between 18 and 65 years.
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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300716

Contacts

Contact: Lillian Nguyen, BS

503-494-7240

nguyelil@ohsu.edu

Locations

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

Investigators

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lovera JF, Frohman E, Brown TR, Bandari D, Nguyen L, Yadav V, Stuve O, Karman J, Bogardus K, Heimburger G, Cua L, Remingon G, Fowler J, Monahan T, Kilcup S, Courtney Y, McAleenan J, Butler K, Wild K, Whitham R, Bourdette D. Memantine for cognitive impairment in multiple sclerosis: a randomized placebo-controlled trial. Mult Scler. 2010 Jun;16(6):715-23. Epub 2010 May 18.

ClinicalTrials.gov 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
Memantine
Placebo

Neuropsychological tests
Quality of life
Fatigue

Additional relevant MeSH terms:

Cognition Disorders
Multiple Sclerosis
Sclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012