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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819897
Recruitment Status : Terminated
First Posted : January 9, 2009
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

Condition or disease
Clinically Isolated Syndrome

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Study Type : Observational
Actual Enrollment : 37 participants
Time Perspective: Prospective
Official Title: Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.
Study Start Date : June 2008
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Primary Outcome Measures :
  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 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT) [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819897

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Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Principal Investigator: Christine LEBRUN-FRENAY, MDPH University hospital of Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT00819897    
Other Study ID Numbers: 08-PP-05
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: April 2016
Keywords provided by Centre Hospitalier Universitaire de Nice:
Additional relevant MeSH terms:
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Pathologic Processes