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

March 6, 2024 updated by: Ipsen

Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix en Provence, France, 13616
        • Centre Hospitalier du Pays d'Aix
      • Amiens, France, 80054
        • Hôpital Nord - CHU d'Amiens
      • Besancon, France, 25030
        • Hôpital J. Minjoz
      • Bordeaux, France, 33076
        • CHU de Bordeaux
      • Bordeaux, France, 33076
        • Groupe hospitalier Pellegrin
      • Brest, France, 29609
        • Hôpital de la Cavale blanche
      • Bron, France, 69500
        • Hôpital neurologique
      • Cebazat, France, 63118
        • Hôpital Nord
      • Clermont-Ferrand, France, 63003
        • CHU Hôpital Gabriel Montpied
      • Colmar, France, 68024
        • Hôpital Civil de Colmar
      • Creteil, France, 94010
        • Hôpital Henri Mondor
      • Dijon, France, 21000
        • 14 bis Rue du Chapeau Rouge
      • Dijon, France, 21033
        • CHG Dijon
      • Gonesse, France, 95503
        • Centre hospitalier
      • Limoges, France, 87042
        • Hopital Universitaire Dupuytren
      • Mantes La Jolie, France, 78200
        • Centre Hospitalier François
      • Marseille, France, 13008
        • Hôpital Saint Joseph
      • Montpellier, France, 34295
        • Hôpital Gui de Chauliac
      • Nancy, France, 54035
        • Hôpital Central
      • Nantes, France, 44093
        • Hôpital Guillaume et Réne
      • Nice, France, 06002
        • Hôpital Pasteur
      • Paris, France, 75014
        • Hôpital Saint Joseph
      • Paris, France, 75014
        • Hôpital Léopold BELLAN
      • Pontoise, France, 95303
        • Centre Hospitalier René Dubos
      • Quimper, France, 29107
        • Hôpital Laënnec
      • Reims, France, 51092
        • CHU de Reims - Hôpital Maison Blanche
      • Rennes, France, 35033
        • CHU Hôpital de Pontchaillou
      • Rouen, France, 76031
        • Hôpital Charles Nicolle
      • Rouen, France, 76100
        • Cabinet Medical
      • Saint Denis, France, 93205
        • Hopital DELAFONTAINE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2003

Study Completion (Actual)

December 8, 2005

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimated)

January 13, 2006

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-39-00240-126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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