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

NCT03854123 | Completed

• 1 other identifier: CHUBX 2014/02
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Geriatric population; EDMUS; OFSEP

Outcome Measures

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

  At inclusion (day 0)

Secondary Outcomes (13)

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

  At inclusion (day 0)

• Description of the clinical characteristics at 75 years Old

  At inclusion (day 0)

• Description of the Cerebral MRI at 75 years Old

  At inclusion (day 0)

• Description of the paraclinical characteristics at 75 years Old

  At inclusion (day 0)

• Description of the paraclinical characteristics at 75 years Old

  At inclusion (day 0)

Study Arms (1)

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).

Eligibility Criteria

• Age: 75 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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" which includes more than 50 000 MS patients in France.

You may qualify if:

• Patients whose beginning of MS was before 65 years old or 65 years old
• Patients who signed OFSEP 's consent

You may not qualify if:

• Patients whose clinical data cannot be entered or for whom too much clinical data are missing
• Patients died before 65 years old

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Observatoire Français de la sclérose en plaques (OFSEP): collaborator
• Novartis: collaborator

Study Sites (3)

CHU de Bordeaux - Pellegrin - service de neurologie

Bordeaux, France

Location

Hôpital neurologique - Pierre Wertheimer

Bron, France

Location

CHU de Rennes - service de neurologie

Rennes, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jean-Christophe OUALLET, MD, PhD

  CHU de Bodeaux

  PRINCIPAL INVESTIGATOR

• Sandra VUKUSIC, Prof.

  Observatoire Français de la sclérose en plaques (OFSEP)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: February 26, 2019
• Study Start: September 21, 2018
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

FR (3)