Status:
COMPLETED
Trial of Memantine for Cognitive Impairment in Multiple Sclerosis
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Forest Laboratories
University of Southern California
Conditions:
Multiple Sclerosis
Cognition Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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.
Detailed Description
Objective: The objective of this pilot project is to conduct a clinical trial to assess the efficacy of memantine as a treatment for cognitive dysfunction in multiple sclerosis (MS). We hypothesize t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00300716
Start Date
April 1 2004
End Date
January 1 2009
Last Update
October 15 2019
Active Locations (4)
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1
USC
Los Angeles, California, United States, 90033
2
OHSU
Portland, Oregon, United States, 97201
3
UT Southwestern
Dallas, Texas, United States, 75390-9036
4
MS Hub
Seattle, Washington, United States, 98101