Clinical trial NCT00276341: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: cognitive impairment
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
Secondary outcomes:
measure: Evolution of the following tests between baseline and week 24:
measure: Multiple Sclerosis Functional Composite Test
measure: Selective Reminding Test
measure: 10/36 Visual-Spatial Recall Test
measure: Symbol Digit Modalities Test
measure: Trail Making Test A and B
measure: Verbal Fluency Test
measure: Empan Test
measure: Evolution of the following scales between baseline and week 24:
measure: Cognitive Deficit Interview based screen
measure: Anxiety Brief Scale
measure: Beck Depression Inventory Scale
measure: Modified Fatigue Impact Scale
measure: Evolution of Quality of Life
measure: Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Amiens
country: France
facility: Hôpital Nord - CHU d'Amiens
city: Besancon
country: France
facility: Hôpital J. Minjoz
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Brest
country: France
facility: Hôpital de la cavale Blanche
city: Bron
country: France
facility: Hôpital Neurologique
city: Cebazat
country: France
facility: Hopital Nord
city: Clermont-Ferrand
country: France
facility: CHU Hôpital Gabriel Montpied
city: Colmar
country: France
facility: Hôpital Civil de Colmar
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: 14 bis Rue du Chapeau Rouge
city: Dijon
country: France
facility: CHG Dijon
city: Gonesse
country: France
facility: Centre Hospitalier
city: Limoges
country: France
facility: Hôpital Universitaire Dupuytren
city: Mantes La Jolie
country: France
facility: Centre Hospitalier François
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nancy
country: France
facility: Hôpital Central
city: Nantes
country: France
facility: Hôpital Guillaume et Réne
city: Nice
country: France
facility: Hôpital Pasteur
city: Paris
country: France
facility: Hôpital Léopold Bellan
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Quimper
country: France
facility: Hôpital Laënnec
city: Reims
country: France
facility: CHU de Reims - Hôpital Maison Blanche
city: Rennes
country: France
facility: CHU Hôpital de Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Rouen
country: France
facility: Cabinet Médical
city: Saint Denis
country: France
facility: Hôpital Delafontaine
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: