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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Terminated

CT.gov ID

NCT00819897

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinically Isolated Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

37 participants

Time Perspective:

Prospective

Official Title:

Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	Hôpital Roger Salengro	Lille	France
6	Hôpital de Saint Philibert	Lomme	France
7	Centre Hospitalier de la Timone	Marseille	France
8	Hôpital Gui de Chauliac	Montpellier	France
9	CHU de Nancy	Nancy	France
10	CHU de Nantes	Nantes	France
11	CHU Nice	Nice	France	06000
12	CHU de Montpellier-Nîmes - Hôpital Caremeau	Nîmes	France
13	Hôpital de Poissy	Poissy	France
14	CHU de Reims	Reims	France
15	Hôpital Pontchaillon	Rennes	France
16	CHRU de Strasbourg	Strasbourg	France
17	Hôpital Purpan	Toulouse	France