Study on the Effectiveness of EGb 761® Vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00276341
First received: January 12, 2006
Last updated: May 15, 2006
Last verified: May 2006
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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
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 May 23, 2013