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

Completed

• Conditions: Progressive Multiple Sclerosis

• Registration Number: NCT03302806
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06-29
• Study First Submitted: 2017-10-02
• Primary Completion: 2017-10-04
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-05
• Study Completion: 2018-10-24
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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)

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Exclusion Criteria

• Patient with remittent recurrent multiple sclerosis
• Pregnant women or women contemplating pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of post-treatment disability	12 months	Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period

Secondary Outcome Measures

Name	Time	Method
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
adverse effect (adverse drug reaction)	12 months	number of AE
Quality of life	12 months	Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France