Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
cognitive impairment
Brief summary
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.
Interventions
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Evolution of the following tests between baseline and week 24: | — |
| Multiple Sclerosis Functional Composite Test | — |
| Selective Reminding Test | — |
| Anxiety Brief Scale | — |
| 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 | — |
| 10/36 Visual-Spatial Recall Test | — |
Countries
France
Outcome results
None listed