MedDataX Logo

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

NCT ID: NCT00819897

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients

NCT00928967

Multiple Sclerosis
COMPLETED

Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients

NCT01201343

Multiple Sclerosis, Relapsing, Remitting
COMPLETED PHASE4

Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b

NCT03408093

Multiple Sclerosis
COMPLETED

A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome

NCT00287079

Clinically Isolated Syndrome
COMPLETED PHASE3

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

NCT06455332

Clinically Isolated Syndrome Multiple Sclerosis
RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinically Isolated Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christine LEBRUN-FRENAY, MDPH

Role: PRINCIPAL_INVESTIGATOR

University hospital of Nice

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, , France

Site Status

University hospital of Côte de Nacre

Caen, , France

Site Status

Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Hôpital Général de DIJON

Dijon, , France

Site Status

Hôpital Roger Salengro

Lille, , France

Site Status

Hôpital de Saint Philibert

Lomme, , France

Site Status

Centre Hospitalier de la Timone

Marseille, , France

Site Status

Hôpital Gui de Chauliac

Montpellier, , France

Site Status

CHU de Nancy

Nancy, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

CHU Nice

Nice, , France

Site Status

CHU de Montpellier-Nîmes - Hôpital Caremeau

Nîmes, , France

Site Status

Hôpital de Poissy

Poissy, , France

Site Status

CHU de Reims

Reims, , France

Site Status

Hôpital Pontchaillon

Rennes, , France

Site Status

CHRU de Strasbourg

Strasbourg, , France

Site Status

Hôpital Purpan

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08-PP-05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple Sclerosis
NCT02937285 COMPLETED PHASE3
Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis
NCT01371071 UNKNOWN
A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
NCT02587195 COMPLETED PHASE3
A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
NCT03347370 COMPLETED
EARLY IFNB-1a and Simvastatin Combination Therapy in Clinically Isolated Syndrome Suggestive of Multiple Sclerosis
NCT00146068 COMPLETED PHASE4
The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
NCT00917839 UNKNOWN PHASE2
Optimizing IFN Beta - 1B Dose
NCT00473213 COMPLETED PHASE3
Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant
NCT01392872 COMPLETED NA
Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
NCT00219908 TERMINATED PHASE2
Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
NCT04510350 COMPLETED
Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis
NCT01491100 COMPLETED
RNF and Betaseron® Tolerability Study
NCT00428584 COMPLETED PHASE3
Multiple Sclerosis: Chi3L1 and Treatment Efficacy
NCT04289675 COMPLETED
An Observational Study of Multiple Sclerosis (MS) Patients Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment With Mitoxantrone
NCT01142518 COMPLETED
Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis
NCT00492765 COMPLETED PHASE4
Long-Term Safety and Efficacy Study of Peginterferon Beta-1a
NCT01332019 COMPLETED PHASE3
The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment
NCT01067573 COMPLETED
Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?
NCT00534261 COMPLETED PHASE4
Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis
NCT01074346 COMPLETED
An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) Patients
NCT01142453 COMPLETED
Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis
NCT00489489 COMPLETED PHASE2
Multimodal MRI in Multiple Sclerosis (MS): Reliability and Follow Up
NCT00289159 UNKNOWN
Prognostic Value of Cerebrospinal Fluid Immunoglobulin Free Light Chains in Patients With Multiple Sclerosis
NCT05072691 RECRUITING
QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in Korea
NCT01071694 WITHDRAWN
A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
NCT00883337 COMPLETED PHASE3