Clinical trial NCT00819897: Longitudinal Study in Clinically Isolated Syndrome (CIS) Patients Treated With Interferon Beta
Official title: Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Clinically Isolated Syndrome
Keywords: MS
CIS
IFN
MRI
OCT
QOL
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with CIS and temporo spatial dissemination for less than one year without prior immunomodulatory treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT)
timeFrame: 3 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Caen
country: France
facility: University hospital of Côte de Nacre
city: Clermont-ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Dijon
country: France
facility: Hôpital Général de DIJON
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Lomme
country: France
facility: Hôpital de Saint Philibert
city: Marseille
country: France
facility: Centre Hospitalier de la Timone
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU de Montpellier-Nîmes - Hôpital Caremeau
city: Poissy
country: France
facility: Hôpital de Poissy
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: Hôpital Pontchaillon
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: Hôpital Purpan
Study officials:
affiliation: University hospital of Nice
name: Christine LEBRUN-FRENAY, MDPH
role: PRINCIPAL_INVESTIGATOR
References: