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

Ipsen

Status and phase

Completed

Phase 3

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: EGb 761® (Tanakan®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00276341

2-39-00240-126

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)