Longitudinal Study in Clinically Isolated Syndrome (CIS) Patients Treated With Interferon Beta (QUALICIS)
This study has been terminated.
Sponsor:
Department of Clinical Research and Innovation
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00819897
First received: January 8, 2009
Last updated: December 6, 2011
Last verified: December 2011
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Purpose
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 |
|---|
|
Clinically Isolated Syndrome |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life. |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nice:
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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 37 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patient with CIS and temporo spatial dissemination for less than one year without prior immunomodulatory treatment
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819897
Locations
| 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, 06000 | |
| 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, France | |
Sponsors and Collaborators
Department of Clinical Research and Innovation
Investigators
| Principal Investigator: | Christine LEBRUN-FRENAY, MDPH | University hospital of Nice |
More Information
No publications provided
| Responsible Party: | Department of Clinical Research and Innovation, LEBRUN-FRENAY, Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT00819897 History of Changes |
| Other Study ID Numbers: | 08-PP-05 |
| Study First Received: | January 8, 2009 |
| Last Updated: | December 6, 2011 |
| Health Authority: | France: Institutional Ethical Committee |
Keywords provided by Centre Hospitalier Universitaire de Nice:
|
MS CIS IFN |
MRI OCT QOL |
Additional relevant MeSH terms:
|
Interferon-beta Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013