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

Clinically Isolated Syndrome Clinical Trial

— QUALICIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00819897
• Other study ID #: 08-PP-05
• Status: Terminated
• Phase: N/A
• First received: January 8, 2009
• Last updated: May 11, 2016
• Start date: June 2008
• Est. completion date: June 2014

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Syndrome

Locations

Country	Name	City	State
France	CHU de Bordeaux - Hôpital Pellegrin	Bordeaux
France	University hospital of Côte de Nacre	Caen
France	Hôpital Gabriel Montpied	Clermont-ferrand
France	Hôpital Général de DIJON	Dijon
France	Hôpital Roger Salengro	Lille
France	Hôpital de Saint Philibert	Lomme
France	Centre Hospitalier de la Timone	Marseille
France	Hôpital Gui de Chauliac	Montpellier
France	CHU de Nancy	Nancy
France	CHU de Nantes	Nantes
France	CHU Nice	Nice
France	CHU de Montpellier-Nîmes - Hôpital Caremeau	Nîmes
France	Hôpital de Poissy	Poissy
France	CHU de Reims	Reims
France	Hôpital Pontchaillon	Rennes
France	CHRU de Strasbourg	Strasbourg
France	Hôpital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT)		3 years	No