Status:
COMPLETED
Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis
Lead Sponsor:
Ipsen
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 26 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2005
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00276341
Start Date
August 26 2003
End Date
December 8 2005
Last Update
March 7 2024
Active Locations (30)
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1
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France, 13616
2
Hôpital Nord - CHU d'Amiens
Amiens, France, 80054
3
Hôpital J. Minjoz
Besançon, France, 25030
4
CHU de Bordeaux
Bordeaux, France, 33076