Clinically Isolated SyndromeQUALICISNCT00819897
Longitudinal Study in Clinically Isolated Syndrome (CIS) Patients Treated With Interferon Beta
An observational study of Clinically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nice at 17 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinically Isolated Syndrome
- How many people
- 37 participants
- Where
- 17 sitesFrance
- Study dates
- Jun 2008to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with CIS and temporo spatial dissemination for less than one year without prior immunomodulatory treatment
Who may be able to join
- 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
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- Patients informed of study protocol
- Patients agree to sign informed consent
- Patients with affiliation number from social French département.
Who cannot join
- 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
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- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux
University hospital of Côte de Nacre
Caen
Hôpital Gabriel Montpied
Clermont-Ferrand
Hôpital Général de DIJON
Dijon
Hôpital Roger Salengro
Lille
Hôpital de Saint Philibert
Lomme
Centre Hospitalier de la Timone
Marseille
Hôpital Gui de Chauliac
Montpellier
CHU de Nancy
Nancy
CHU de Nantes
Nantes
CHU Nice
Nice, 06000
CHU de Montpellier-Nîmes - Hôpital Caremeau
Nîmes
Hôpital de Poissy
Poissy
CHU de Reims
Reims
Hôpital Pontchaillon
Rennes
CHRU de Strasbourg
Strasbourg
Hôpital Purpan
Toulouse
About this study
Official title: Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.
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.
- Conditions
- Clinically Isolated Syndrome
- Keywords
- MS, CIS, IFN, MRI, OCT, QOL
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Isolated SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine LEBRUN-FRENAY, MDPH, Principal investigator, University hospital of Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819897
- Sponsor's protocol ID
- 08-PP-05
- Acronym
- QUALICIS
- Status last verified
- Apr 2016
- First submitted
- 8 Jan 2009
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.
- ClinicalTrials.gov ID
- NCT00819897
- Acronym / sponsor ID
- QUALICIS / 08-PP-05
- Conditions
- Clinically Isolated Syndrome
- Keywords
- MS, CIS, IFN, MRI, OCT, QOL
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with CIS and temporo spatial dissemination for less than one year without prior immunomodulatory treatment
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- Secondary progressive MS
- Patient with acute relapse
- Patient already treated with IFN
- corticosteroids less than 15 days
- Patient with severe dépressive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT)
Time frame: 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine LEBRUN-FRENAY, MDPH principal investigator
University hospital of Nice
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nice at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.