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

CompletedPhase 3

Sponsor: Ipsen

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: EGb 761® (Tanakan®)

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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)

Locations (30)

Aix-en-Provence, France
Amiens, France
Besançon, France
Bordeaux, France
Bordeaux, France
Brest, France
Bron, France
Cébazat, France
Clermont-Ferrand, France
Colmar, France
Créteil, France
Dijon, France
Dijon, France
Gonesse, France
Limoges, France
Mantes-la-Jolie, France
Marseille, France
Montpellier, France
Nancy, France
Nantes, France
Nice, France
Paris, France
Paris, France
Pontoise, France
Quimper, France
Reims, France
Rennes, France
Rouen, France
Rouen, France
Saint-Denis, France