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
Sponsor:
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
First received: March 8, 2006
Last updated: August 27, 2009
Last verified: April 2007
  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 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  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 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:
No publications provided by Oregon Health and Science University

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

ClinicalTrials.gov processed this record on August 27, 2014