Multiple SclerosisOLDMUSNCT03854123
Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics
An observational study of Multiple Sclerosis, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 77 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 159 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Sep 2018to 23 Sep 2020
- 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 75 to 77 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Bordeaux - Pellegrin - service de neurologie
Bordeaux
Hôpital neurologique - Pierre Wertheimer
Bron
CHU de Rennes - service de neurologie
Rennes
About this study
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.
Read the 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
- Multiple Sclerosis
- Keywords
- Geriatric population, EDMUS, OFSEP
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At inclusion (day 0)
Description of the clinical characteristics at 75 years Old
Clinical conversion to secondary progressive MS date
Measured: At inclusion (day 0)
Description of the Cerebral MRI at 75 years Old
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,
Measured: At inclusion (day 0)
Description of the paraclinical characteristics at 75 years Old
Distance walked (with or without help)
Measured: At inclusion (day 0)
Description of the paraclinical characteristics at 75 years Old
Barthel index
Measured: At inclusion (day 0)
Socio-demographic data
sex
Measured: At inclusion (day 0)
Socio-demographic data
age
Measured: At inclusion (day 0)
Socio-demographic data
department of residence
Measured: At inclusion (day 0)
Description of the treatments at 75 years Old
Treatments of multiple sclerosis
Measured: At inclusion (day 0)
Description of the treatments at 75 years Old
Failures treatments of multiple sclerosis
Measured: At inclusion (day 0)
Description of the treatments at 75 years Old
Side effects of treatments and other concomitant treatments
Measured: At inclusion (day 0)
Measure of health-related quality of life at 75 years Old
EQ-5D Instruments
Measured: At inclusion (day 0)
Evaluation of cognitive functions at 75 years Old
Symbol digit modalities test (SDMT) test
Measured: At inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start21 Sep 2018
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Observatoire Français de la sclérose en plaques (OFSEP), Novartis
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe OUALLET, MD, PhD, Principal investigator, CHU de BodeauxSandra VUKUSIC, Prof., Study chair, Observatoire Français de la sclérose en plaques (OFSEP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854123
- Sponsor's protocol ID
- CHUBX 2014/02
- Acronym
- OLDMUS
- Status last verified
- Feb 2022
- First submitted
- 5 Apr 2018
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics
- ClinicalTrials.gov ID
- NCT03854123
- Acronym / sponsor ID
- OLDMUS / CHUBX 2014/02
- Conditions
- Multiple Sclerosis
- Keywords
- Geriatric population, EDMUS, OFSEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Observatoire Français de la sclérose en plaques (OFSEP), Novartis
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 26 Feb 2019 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 75 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
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
13 secondary outcomes
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)
Description of the clinical characteristics at 75 years Old
Time frame: At inclusion (day 0)
Description of the Cerebral MRI at 75 years Old
Time frame: At inclusion (day 0)
Description of the paraclinical characteristics at 75 years Old
Time frame: At inclusion (day 0)
Description of the paraclinical characteristics at 75 years Old
Time frame: At inclusion (day 0)
Socio-demographic data
Time frame: At inclusion (day 0)
Socio-demographic data
Time frame: At inclusion (day 0)
Socio-demographic data
Time frame: At inclusion (day 0)
Description of the treatments at 75 years Old
Time frame: At inclusion (day 0)
Description of the treatments at 75 years Old
Time frame: At inclusion (day 0)
Description of the treatments at 75 years Old
Time frame: At inclusion (day 0)
Measure of health-related quality of life at 75 years Old
Time frame: At inclusion (day 0)
Evaluation of cognitive functions at 75 years Old
Time frame: At inclusion (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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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.
Jean-Christophe OUALLET, MD, PhD principal investigator
CHU de Bodeaux
Sandra VUKUSIC, Prof. study chair
Observatoire Français de la sclérose en plaques (OFSEP)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Bordeaux at 3 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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)). 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 3 Feb 2022.