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NCT Number: NCT03854123

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

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.

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Key information

Age range

75 year–77 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux - Pellegrin - service de neurologie, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of MS evolution with disability progression (irreversible Disability Status Scale) in 75 to 77 years Old MS Patients from the age of 65 years-old to present time

    Time frame: At inclusion (day 0)

    Time to reach the irreversible Kurtzke disability status scale (DSS) score 4, 6 and 7

Secondary outcomes

  1. Frequency of clinical relapses in 75 years Old or Older MS Patients from the age of 65 years-old to present time

    Time frame: At inclusion (day 0)

  2. Description of the clinical characteristics at 75 years Old

    Time frame: At inclusion (day 0)

    Clinical conversion to secondary progressive MS date

  3. Description of the Cerebral MRI at 75 years Old

    Time frame: At inclusion (day 0)

    Number of lesions on T2 sequence if <9, number of new T2 lesions, Number of Gadolinium enhancing lesions, T1-Hypointense Lesions (T1 Black Holes), MRI Barkhof Criteria and number of periventricular lesions if <3,

  4. Description of the paraclinical characteristics at 75 years Old

    Time frame: At inclusion (day 0)

    Distance walked (with or without help)

  5. Description of the paraclinical characteristics at 75 years Old

    Time frame: At inclusion (day 0)

    Barthel index

  6. Socio-demographic data

    Time frame: At inclusion (day 0)

    sex

  7. Socio-demographic data

    Time frame: At inclusion (day 0)

    age

  8. Socio-demographic data

    Time frame: At inclusion (day 0)

    department of residence

  9. Description of the treatments at 75 years Old

    Time frame: At inclusion (day 0)

    Treatments of multiple sclerosis

  10. Description of the treatments at 75 years Old

    Time frame: At inclusion (day 0)

    Failures treatments of multiple sclerosis

  11. Description of the treatments at 75 years Old

    Time frame: At inclusion (day 0)

    Side effects of treatments and other concomitant treatments

  12. Measure of health-related quality of life at 75 years Old

    Time frame: At inclusion (day 0)

    EQ-5D Instruments

  13. Evaluation of cognitive functions at 75 years Old

    Time frame: At inclusion (day 0)

    Symbol digit modalities test (SDMT) test

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Novartis
  • Observatoire Français de la sclérose en plaques (OFSEP)

Registry information

Acronym: OLDMUS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2019
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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