Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis
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.
1 other identifier
interventional
47
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2003
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 26, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2005
CompletedFirst Submitted
Initial submission to the registry
January 12, 2006
CompletedFirst Posted
Study publicly available on registry
January 13, 2006
CompletedMarch 7, 2024
March 1, 2024
January 12, 2006
March 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
Secondary Outcomes (15)
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
- +10 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (30)
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13616, France
Hôpital Nord - CHU d'Amiens
Amiens, 80054, France
Hôpital J. Minjoz
Besançon, 25030, France
CHU de Bordeaux
Bordeaux, 33076, France
Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
Hôpital de la cavale Blanche
Brest, 29609, France
Hôpital Neurologique
Bron, 69500, France
Hopital Nord
Cébazat, 63118, France
CHU Hôpital Gabriel Montpied
Clermont-Ferrand, 63003, France
Hôpital Civil de Colmar
Colmar, 68024, France
Hôpital Henri Mondor
Créteil, 94010, France
14 bis Rue du Chapeau Rouge
Dijon, 21000, France
CHG Dijon
Dijon, 21033, France
Centre Hospitalier
Gonesse, 95503, France
Hôpital Universitaire Dupuytren
Limoges, 87042, France
Centre Hospitalier François
Mantes-la-Jolie, 78200, France
Hôpital Saint Joseph
Marseille, 13008, France
Hôpital Gui de Chauliac
Montpellier, 34295, France
Hôpital Central
Nancy, 54035, France
Hôpital Guillaume et Réne
Nantes, 44093, France
Hôpital Pasteur
Nice, 06002, France
Hôpital Léopold Bellan
Paris, 75014, France
Hôpital Saint Joseph
Paris, 75014, France
Centre Hospitalier René Dubos
Pontoise, 95303, France
Hôpital Laënnec
Quimper, 29107, France
CHU de Reims - Hôpital Maison Blanche
Reims, 51092, France
CHU Hôpital de Pontchaillou
Rennes, 35033, France
Hôpital Charles Nicolle
Rouen, 76031, France
Cabinet Médical
Rouen, 76100, France
Hôpital Delafontaine
Saint-Denis, 93205, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 12, 2006
First Posted
January 13, 2006
Study Start
August 26, 2003
Study Completion
December 8, 2005
Last Updated
March 7, 2024
Record last verified: 2024-03