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TerminatedNCT00819897QUALICISUpdated May 12, 2016

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

An observational study in Clinically Isolated Syndrome, sponsored by Centre Hospitalier Universitaire de Nice. Terminated at 17 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Clinically Isolated Syndrome

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Keywords

  • MS
  • CIS
  • IFN
  • MRI
  • OCT
  • QOL
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 37 is below the median of 102 across 2,209 observational studies indexed under Syndrome.

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Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Time perspective
Prospective
Enrollment
37 participants (actual)
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What researchers measure

Primary outcomes

  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 outcomes

  1. Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT)

    Time frame: 3 years

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Study locations

17 sites
  • 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, 06000, 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, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00819897
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jan 9, 2009
Start date
Jun 2008
Primary completion
Jun 2014
Completion
Jun 2014
Last update
May 12, 2016

Study contacts

Christine LEBRUN-FRENAY, MDPH
principal investigator · University hospital of Nice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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