NCT03302806
Completed
N/A
Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
ConditionsProgressive Multiple Sclerosis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Progressive Multiple Sclerosis
- Sponsor
- Nantes University Hospital
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Evolution of post-treatment disability
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evolution of post-treatment disability
Time Frame: 12 months
Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period
Secondary Outcomes
- CGI-t scale(after 6 months and 12 months)
- Functional disability : Multiple sclerosis Functional composite(12 months)
- Ambulation(12 months)
- adverse effect (adverse drug reaction)(12 months)
- Quality of life(12 months)
Study Sites (1)
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