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

Phase 3

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Registration Number: NCT00276341
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08-26
• Study Completion: 2005-12-08
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24

Secondary Outcome Measures

Name	Time	Method
10/36 Visual-Spatial Recall Test
Symbol Digit Modalities Test
Trail Making Test A and B
Beck Depression Inventory Scale
Selective Reminding Test
Verbal Fluency Test
Empan Test
Evolution of the following scales between baseline and week 24:
Cognitive Deficit Interview based screen
Anxiety Brief Scale
Evolution of the following tests between baseline and week 24:
Multiple Sclerosis Functional Composite Test
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

Trial Locations

Locations (29)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Hopital Nord; 🇫🇷 Cebazat, France

CHG Dijon; 🇫🇷 Dijon, France

Hôpital Henri Mondor; 🇫🇷 Creteil, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

Hôpital Universitaire Dupuytren; 🇫🇷 Limoges, France

Hôpital de la cavale Blanche; 🇫🇷 Brest, France

Centre Hospitalier René Dubos; 🇫🇷 Pontoise, France

14 bis Rue du Chapeau Rouge; 🇫🇷 Dijon, France

Hôpital Central; 🇫🇷 Nancy, France

Hôpital Guillaume et Réne; 🇫🇷 Nantes, France

Hôpital Léopold Bellan; 🇫🇷 Paris, France

Hôpital J. Minjoz; 🇫🇷 Besancon, France

Hôpital Nord - CHU d'Amiens; 🇫🇷 Amiens, France

Centre Hospitalier du Pays d'Aix; 🇫🇷 Aix en Provence, France

Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

CHU Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Hôpital Civil de Colmar; 🇫🇷 Colmar, France

Centre Hospitalier; 🇫🇷 Gonesse, France

Hôpital Neurologique; 🇫🇷 Bron, France

Hôpital Saint Joseph; 🇫🇷 Paris, France

Centre Hospitalier François; 🇫🇷 Mantes La Jolie, France

Hôpital Pasteur; 🇫🇷 Nice, France

Cabinet Médical; 🇫🇷 Rouen, France

Hôpital Laënnec; 🇫🇷 Quimper, France

CHU Hôpital de Pontchaillou; 🇫🇷 Rennes, France

CHU de Reims - Hôpital Maison Blanche; 🇫🇷 Reims, France

Hôpital Delafontaine; 🇫🇷 Saint Denis, France