Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis

Nantes University Hospital103 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

103

Conditions

Progressive Multiple Sclerosis

Interventions

Non interventional StudyOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nantes University Hospital

Nantes, France

Outcomes

Primary Outcomes

Evolution of post-treatment disability

Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period

Time frame: 12 months

Secondary Outcomes

CGI-t scale

Change in Clinical global impression of improvement from both physician and patient assessments

Time frame: after 6 months and 12 months

Functional disability : Multiple sclerosis Functional composite

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

Time frame: 12 months

Ambulation

Change in MSWS-12 score from baseline

Time frame: 12 months

Quality of life

Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline

Time frame: 12 months

adverse effect (adverse drug reaction)

number of AE

Time frame: 12 months

Data from ClinicalTrials.gov

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