Clinical Trials Directory

Trials / Completed

CompletedNCT03854123

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

Status
Completed
Phase
Study type
Observational
Enrollment
159 (actual)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
All
Age
75 Years – 77 Years
Healthy volunteers
Not accepted

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.

Detailed description

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

Timeline

Start date
2018-09-21
Primary completion
2020-09-23
Completion
2020-09-23
First posted
2019-02-26
Last updated
2022-02-03

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03854123. Inclusion in this directory is not an endorsement.