Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics

NCT ID: NCT03854123

Last Updated: 2022-02-03

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

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-21

Study Completion Date

2020-09-23

Brief Summary

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Little is known about old MS patients. In a previous work, systematic search in Bordeaux, Strasbourg and Dijon university hospital regional MS center databases European Database for Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS) patients in the 3 databases. Data analysis showed that MS may switch off in the very old patients with mild progression and very few relapses. The project is to continue this preliminary work and extend it with a systematic study of MS in the elderly.

The scientific aims: To add new insights into long lasting MS natural history in the growing population of elderly patients with MS.

Detailed Description

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75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP) which includes more than 50 000 MS patients in France. Accuracy of these patients' data from 65 to 75 years old will be thereafter checked and completed in 3 French MS centers: Lyon, Rennes and Bordeaux, participating to this database directly from the patients' clinical files. From these 3 MS centers around 150 MS patients from 75 to 77 years old are expected to be analysed on site.

The data wich will be retrieved for these patients are: irreversible disability status scale progression, relapses, Magnetic Resonance Imaging (MRI) data, CSF data, Lublin classification of type of MS, McDonald 2005 and 2010 criteria, date and age at beginning of progression, characteristics and modality of relapses and clinical impairment at the beginning of the disease, treatments used, treatment failures and side effects, co morbidity, Barthel index, EuroQol-5D (EQ-5D), cognitive impairment (SDMT test), social life data and socio economic data. To the investigator's knowledge this will be the first systematic description of very old MS patients with data on long term natural history of MS and characteristics in this population of elderly MS patients.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Old MS patients

75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with McDonald 2001, 2005 or 2010 criteria of multiple sclerosis 75 to 77 years old MS patients at the time of inclusion
* Patients whose beginning of MS was before 65 years old or 65 years old
* Patients who signed OFSEP 's consent

Exclusion Criteria

* Patients whose clinical data cannot be entered or for whom too much clinical data are missing
* Alive patients older than 77 years or younger than 75 years the day of the inclusion in the study
* Patients died before 65 years old
Minimum Eligible Age

75 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Observatoire Français de la sclérose en plaques (OFSEP)

UNKNOWN

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe OUALLET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Bodeaux

Sandra VUKUSIC, Prof.

Role: STUDY_CHAIR

Observatoire Français de la sclérose en plaques (OFSEP)

Locations

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CHU de Bordeaux - Pellegrin - service de neurologie

Bordeaux, , France

Site Status

Hôpital neurologique - Pierre Wertheimer

Bron, , France

Site Status

CHU de Rennes - service de neurologie

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2014/02

Identifier Type: -

Identifier Source: org_study_id

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