CClinicalTrials.gg
CompletedNCT00276341Updated Mar 7, 2024

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

A Phase 3 interventional study of EGb 761® (Tanakan®) in Multiple Sclerosis, Relapsing-Remitting, sponsored by Ipsen. Completed at 30 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Ipsen · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Aug 2003, registered Jan 2006).
Phase
Phase 3
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting

Keywords

  • cognitive impairment
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 660 are open to participants now.

This study's enrollment of 47 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
47 participants (actual)

Interventions

  • DrugEGb 761® (Tanakan®)
06

What researchers measure

Primary outcomes

  1. Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24

Secondary outcomes

  1. Evolution of the following tests between baseline and week 24:

  2. Multiple Sclerosis Functional Composite Test

  3. Selective Reminding Test

  4. 10/36 Visual-Spatial Recall Test

  5. Symbol Digit Modalities Test

  6. Trail Making Test A and B

  7. Verbal Fluency Test

  8. Empan Test

  9. Evolution of the following scales between baseline and week 24:

  10. Cognitive Deficit Interview based screen

  11. Anxiety Brief Scale

  12. Beck Depression Inventory Scale

  13. Modified Fatigue Impact Scale

  14. Evolution of Quality of Life

  15. Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change

07

Study locations

30 sites
  • Centre Hospitalier du Pays d'Aix
    Aix en Provence, 13616, France
  • Hôpital Nord - CHU d'Amiens
    Amiens, 80054, France
  • Hôpital J. Minjoz
    Besancon, 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
    Cebazat, 63118, France
  • CHU Hôpital Gabriel Montpied
    Clermont-Ferrand, 63003, France
  • Hôpital Civil de Colmar
    Colmar, 68024, France
  • Hôpital Henri Mondor
    Creteil, 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00276341
Lead sponsor
Ipsen
First posted
Jan 13, 2006
Start date
Aug 26, 2003
Completion
Dec 8, 2005
Last update
Mar 7, 2024

Study contacts

Ipsen Medical Director
study director · Ipsen
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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