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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen

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)