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

Progressive Multiple Sclerosis Clinical Trial

— BIOSEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302806
• Other study ID #: RC16_0232
• Status: Completed
• Start date: June 29, 2016
• Est. completion date: October 24, 2018

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 24, 2018
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Progressive Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Non interventional Study

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of post-treatment disability	Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period	12 months
Secondary	CGI-t scale	Change in Clinical global impression of improvement from both physician and patient assessments	after 6 months and 12 months
Secondary	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	12 months
Secondary	Ambulation	Change in MSWS-12 score from baseline	12 months
Secondary	Quality of life	Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline	12 months
Secondary	adverse effect (adverse drug reaction)	number of AE	12 months