Overview
Trial of Memantine for Cognitive Impairment in Multiple Sclerosis
Status:
Completed
Completed
Trial end date:
2009-01-01
2009-01-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Oregon Health and Science UniversityCollaborators:
Forest Laboratories
MS-Hub Seattle
University of Southern California
University of Texas Southwestern Medical CenterTreatments:
Memantine
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.