Status:

TERMINATED

Longitudinal Study in Clinically Isolated Syndrome (CIS) Patients Treated With Interferon Beta

Lead Sponsor:

Centre Hospitalier Universitaire de Nice

Conditions:

Clinically Isolated Syndrome

Eligibility:

All Genders

18+ years

Brief Summary

The aim of this study is to evaluate the role of cognitive disorders and quality of life in patients with CIS, considered as high risk to develop an MS, treated with interferon Beta. This prospective ...

Eligibility Criteria

Inclusion

  • Patients older than 18 years,
  • Patients with CIS and temporo spatial dissemination for less than one year
  • Patient without prior immunomodulatory treatment
  • Patient informed of CIS diagnosis and MS according to McDonald criteria,
  • Patients with EDSS inferior or egal to 5,5
  • Patients usually french-reader and with MMS \>24
  • Patients informed of study protocol
  • Patients agree to sign informed consent
  • Patients with affiliation number from social French département.

Exclusion

  • Secondary progressive MS
  • Patient with acute relapse
  • Patient already treated with IFN
  • corticosteroids less than 15 days
  • Patient with severe dépressive disorders
  • Patient already included in clinical study
  • Patient \< 18 years
  • Patient with known contra indications for beta interféron
  • Every reason with can provoke an interruption of the study, regarding a patient empechment
  • Contre indications for MRI or other tests required in the study
  • pregnancy or lactation
  • patient Under juridic protection

Key Trial Info

Start Date :

June 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

37 Patients enrolled

Trial Details

Trial ID

NCT00819897

Start Date

June 1 2008

End Date

June 1 2014

Last Update

May 12 2016

Active Locations (17)

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Page 1 of 5 (17 locations)

1

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France

2

University hospital of Côte de Nacre

Caen, France

3

Hôpital Gabriel Montpied

Clermont-Ferrand, France

4

Hôpital Général de DIJON

Dijon, France