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

Terminated

• Conditions: Clinically Isolated Syndrome

• Registration Number: NCT00819897
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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 observational study will include 120 patients, all treated and evaluated annually with neurological extensive examination, ophthalmologic screening (OCT, OF, VEP, VF), auto questionnaire about fatigue (musicol, ELIF), quality of life (SEP-59), and conventional MRI.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical exams performed at Baseline and every year during 3 years Neurological examination: relapses recording and EDSS. Quality of life: SEP-59, MusiQOL. Neuropsychological screening	3 years

Secondary Outcome Measures

Name	Time	Method
Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT)	3 years

Trial Locations

Locations (17)

CHU de Montpellier-Nîmes - Hôpital Caremeau; 🇫🇷 Nîmes, France

CHU Nice; 🇫🇷 Nice, France

Hôpital Roger Salengro; 🇫🇷 Lille, France

CHU de Bordeaux - Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hôpital de Saint Philibert; 🇫🇷 Lomme, France

University hospital of Côte de Nacre; 🇫🇷 Caen, France

Hôpital Général de DIJON; 🇫🇷 Dijon, France

Centre Hospitalier de la Timone; 🇫🇷 Marseille, France

CHU de Nancy; 🇫🇷 Nancy, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont-ferrand, France

Hôpital de Poissy; 🇫🇷 Poissy, France

CHU de Reims; 🇫🇷 Reims, France

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

Hôpital Pontchaillon; 🇫🇷 Rennes, France

Hôpital Purpan; 🇫🇷 Toulouse, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France