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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00276341
First received: January 12, 2006
Last updated: May 15, 2006
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: EGb 761® (Tanakan®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 240
Study Start Date: August 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276341

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

No publications provided

ClinicalTrials.gov Identifier: NCT00276341     History of Changes
Other Study ID Numbers: 2-39-00240-126
Study First Received: January 12, 2006
Last Updated: May 15, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Ipsen:
cognitive impairment

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Cognition Disorders
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014