Status:
COMPLETED
Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Multiple Sclerosis
Cognitive Ability, General
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if treatment with Ginkgo improves cognitive function in people with multiple sclerosis who have cognitive problems.
Detailed Description
Objectives: Primary objective: Determine the difference between subjects treated with Ginkgo biloba (GB) and subjects treated with placebo for 12 weeks on the performance of a battery of neuropsychol...
Eligibility Criteria
Inclusion
- A diagnosis of multiple sclerosis by McDonald's criteria
- Age 18 to 65 years, inclusive
- A score minus one standard deviation below the mean on one or more of the following tests: PASAT, COWAT, CVLT-II, Stroop
- EDSS 0 - 7.5, inclusive
- No Ginkgo biloba in preceding 30 days
- Native English speaker
Exclusion
- Current substance abuse disorder, psychosis, or significant depression (score on the Beck Depression Inventory II (BDI -II) greater than 28
- Any significant uncontrolled medical problem including diabetes requiring insulin
- Relapse of multiple sclerosis within the 30 days before screening
- Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents
- Elective surgery planned for the study period or the following four weeks
- Epilepsy or history of seizures
- Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase inhibitors
- Pregnancy or women not using a reliable form of contraception
- Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia on primary gaze
- Inability to complete the neuropsychological test battery at the screening visit
- History of alcohol abuse or illicit drug use in the prior six months
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00841321
Start Date
January 1 2009
End Date
December 1 2010
Last Update
June 6 2014
Active Locations (2)
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1
Portland VA Medical Center, Portland, OR
Portland, Oregon, United States, 97239
2
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108