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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
EGb 761® (Tanakan®)
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring cognitive impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Centre Hospitalier du Pays d'Aix
  • Hôpital Nord - CHU d'Amiens
  • Hôpital J. Minjoz
  • CHU de Bordeaux
  • Groupe Hospitalier Pellegrin
  • Hôpital de la cavale Blanche
  • Hôpital Neurologique
  • Hopital Nord
  • CHU Hôpital Gabriel Montpied
  • Hôpital Civil de Colmar
  • Hôpital Henri Mondor
  • 14 bis Rue du Chapeau Rouge
  • CHG Dijon
  • Centre Hospitalier
  • Hôpital Universitaire Dupuytren
  • Centre Hospitalier François
  • Hôpital Saint Joseph
  • Hôpital Gui de Chauliac
  • Hôpital Central
  • Hôpital Guillaume et Réne
  • Hôpital Pasteur
  • Hôpital Léopold Bellan
  • Hôpital Saint Joseph
  • Centre Hospitalier René Dubos
  • Hôpital Laënnec
  • CHU de Reims - Hôpital Maison Blanche
  • CHU Hôpital de Pontchaillou
  • Hôpital Charles Nicolle
  • Cabinet Médical
  • Hôpital Delafontaine

Outcomes

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

Full Information

First Posted
January 12, 2006
Last Updated
December 14, 2018
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00276341
Brief Title
Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EGb 761® (Tanakan®)
Primary Outcome Measure Information:
Title
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
Secondary Outcome Measure Information:
Title
Evolution of the following tests between baseline and week 24:
Title
Multiple Sclerosis Functional Composite Test
Title
Selective Reminding Test
Title
10/36 Visual-Spatial Recall Test
Title
Symbol Digit Modalities Test
Title
Trail Making Test A and B
Title
Verbal Fluency Test
Title
Empan Test
Title
Evolution of the following scales between baseline and week 24:
Title
Cognitive Deficit Interview based screen
Title
Anxiety Brief Scale
Title
Beck Depression Inventory Scale
Title
Modified Fatigue Impact Scale
Title
Evolution of Quality of Life
Title
Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier du Pays d'Aix
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
Hôpital Nord - CHU d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hôpital J. Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital de la cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hôpital Neurologique
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Hopital Nord
City
Cebazat
ZIP/Postal Code
63118
Country
France
Facility Name
CHU Hôpital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Civil de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
14 bis Rue du Chapeau Rouge
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHG Dijon
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Centre Hospitalier
City
Gonesse
ZIP/Postal Code
95503
Country
France
Facility Name
Hôpital Universitaire Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier François
City
Mantes La Jolie
ZIP/Postal Code
78200
Country
France
Facility Name
Hôpital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Central
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Hôpital Guillaume et Réne
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Hôpital Léopold Bellan
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Centre Hospitalier René Dubos
City
Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
Hôpital Laënnec
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
CHU de Reims - Hôpital Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Cabinet Médical
City
Rouen
ZIP/Postal Code
76100
Country
France
Facility Name
Hôpital Delafontaine
City
Saint Denis
ZIP/Postal Code
93205
Country
France

12. IPD Sharing Statement

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

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