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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276341
• Other study ID #: 2-39-00240-126
• Status: Completed
• Phase: Phase 3
• Start date: August 26, 2003
• Est. completion date: December 8, 2005

Study information

• Verified date: March 2024
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 8, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• EGb 761® (Tanakan®)

Locations

Country	Name	City	State
France	Centre Hospitalier du Pays d'Aix	Aix en Provence
France	Hôpital Nord - CHU d'Amiens	Amiens
France	Hôpital J. Minjoz	Besancon
France	CHU de Bordeaux	Bordeaux
France	Groupe Hospitalier Pellegrin	Bordeaux
France	Hôpital de la cavale Blanche	Brest
France	Hôpital Neurologique	Bron
France	Hopital Nord	Cebazat
France	CHU Hôpital Gabriel Montpied	Clermont-Ferrand
France	Hôpital Civil de Colmar	Colmar
France	Hôpital Henri Mondor	Creteil
France	14 bis Rue du Chapeau Rouge	Dijon
France	CHG Dijon	Dijon
France	Centre Hospitalier	Gonesse
France	Hôpital Universitaire Dupuytren	Limoges
France	Centre Hospitalier François	Mantes La Jolie
France	Hôpital Saint Joseph	Marseille
France	Hôpital Gui de Chauliac	Montpellier
France	Hôpital Central	Nancy
France	Hôpital Guillaume et Réne	Nantes
France	Hôpital Pasteur	Nice
France	Hôpital Léopold Bellan	Paris
France	Hôpital Saint Joseph	Paris
France	Centre Hospitalier René Dubos	Pontoise
France	Hôpital Laënnec	Quimper
France	CHU de Reims - Hôpital Maison Blanche	Reims
France	CHU Hôpital de Pontchaillou	Rennes
France	Cabinet Médical	Rouen
France	Hôpital Charles Nicolle	Rouen
France	Hôpital Delafontaine	Saint Denis

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

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