Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: EGb 761® (Tanakan®)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EGb 761® (Tanakan®)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| Trail 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 |  |  | 
| Anxiety Brief Scale |  |  | 
| Beck Depression Inventory Scale |  |  | 
| Modified Fatigue Impact Scale |  |  | 
| Evolution of Quality of Life |  |  | 
| Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive impairment