BIOSEP: Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Evolution of post-treatment disability [12 months]
Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period
Secondary Outcome Measures
- 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
Eligibility Criteria
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
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Pregnant women or women contemplating pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Nantes University Hospital | Nantes | France | 44093 |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC16_0232