Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive I
Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.
What it found
We found no results in the registry or in papers.
This trial finished 20 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Ginkgo
What it measured
Main measures
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
Other measures (15)
Evolution of the following tests between baseline and week 24:
Multiple Sclerosis Functional Composite Test
Selective Reminding Test
10/36 Visual-Spatial Recall Test
Symbol Digit Modalities Test
Thinking and memoryTrail Making Test A and B
Verbal Fluency Test
Empan Test
Evolution of the following scales between baseline and week 24:
Cognitive Deficit Interview based screen
Thinking and memory
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
* Patient with Multiple Sclerosis Relapsing-Remitting form * Patient with cognitive impairment (as spontaneous complaint by either patient or family) * Patient treated with interferon and maintaining same dosage for previous 6 months * Patient without major disability (Kurtzke Extended Disability Status Scale ≤6)
Exclusion criteria
* Clinical Multiple Sclerosis relapse within 3 months prior to participation * Major psychiatric disease according to Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. * Other concomitant disorders possibly jeopardizing the cognitive status evaluation or the follow up of the patient (severe impairment of visual or motor function which may prevent participation in neuropsychological testing)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.
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History
Started
Aug 2003
Finished
Dec 2005