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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00819897

Acronym

QUALICIS

Enrollment

Registered

2009-01-09

Start date

2008-06-30

Completion date

2014-06-30

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinically Isolated Syndrome

Keywords

MS, CIS, IFN, MRI, OCT, QOL

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

France

Outcome results