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

NCT00819897 | Terminated

• 1 other identifier: 08-PP-05
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 17

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.

Conditions

Clinically Isolated Syndrome

Keywords

MS; CIS; IFN; MRI; OCT; QOL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with CIS and temporo spatial dissemination for less than one year without prior immunomodulatory treatment

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (17)

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France

Location

University hospital of Côte de Nacre

Caen, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

Hôpital Général de DIJON

Dijon, France

Location

Hôpital Roger Salengro

Lille, France

Location

Hôpital de Saint Philibert

Lomme, France

Location

Centre Hospitalier de la Timone

Marseille, France

Location

Hôpital Gui de Chauliac

Montpellier, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

CHU Nice

Nice, 06000, France

Location

CHU de Montpellier-Nîmes - Hôpital Caremeau

Nîmes, France

Location

Hôpital de Poissy

Poissy, France

Location

CHU de Reims

Reims, France

Location

Hôpital Pontchaillon

Rennes, France

Location

CHRU de Strasbourg

Strasbourg, France

Location

Hôpital Purpan

Toulouse, France

Location

Study Officials

• Christine LEBRUN-FRENAY, MDPH

  University hospital of Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: June 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 12, 2016

Record last verified: 2016-04

Locations

FR (17)