Progressive Multiple Sclerosis
Conditions
Keywords
disability, EDSS
Brief summary
The purpose of this observational study is to collect efficacy and safety data in real life condition within the first year of treatment in patients with progressive multiple receiving a daily dose of biotine of 300 mg.
Interventions
OTHERNon interventional Study
Sponsors
Nantes University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Progressive multiple sclerosis patients with an EDSS score ≤ 7 who have been prescribed high dose of biotin (temporary use administration) at Nantes university hospital (France)
Exclusion criteria
* Patient with remittent recurrent multiple sclerosis * Pregnant women or women contemplating pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of post-treatment disability | 12 months | Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGI-t scale | after 6 months and 12 months | Change in Clinical global impression of improvement from both physician and patient assessments |
| Functional disability : Multiple sclerosis Functional composite | 12 months | Composite score : Change in test measuring the patient's walking speed over a distance of 25 feet(TW25), Symbol Digit Modalities Test (SDMT), 9-Hole Peg Test Scores (9HPT) from baseline |
| Ambulation | 12 months | Change in MSWS-12 score from baseline |
| Quality of life | 12 months | Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline |
| adverse effect (adverse drug reaction) | 12 months | number of AE |
Countries
France
Outcome results
None listed