Study of Biomarkers of the Response to Biotine

Completed

• Conditions: Biotine; Multiple Sclerosis

• Registration Number: NCT03215433
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis (MS) in the context of a nominative temporary authorization for use (TAU) as a disease-modifying treatment for their MS. A recent study showed that with this treatment, more patients experienced an improvement after one year in comparison with patients given a placebo.

The objective of this study is to identify blood biomarkers to determine good responders as early as possible. In addition, the blood parameters studied will make it possible to better understand the mechanisms of action, that have a beneficial effect on multiple sclerosis.

The management of patients will not be modified: same number of consultations (at the prescription, at 3 months, at 12 months), same clinical examination, and the same number of blood samples (at the prescription, at 3 months, and at 12 months).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-08
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Primary Completion: 2019-01-23
• Study Completion: 2019-01-23
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 18 to 65 years old
• inactive progressive form of MS according to the Lublin classification and recorded in the Burgundy EDMUS database
• Patients with health insurance cover
• Patients who have provided written informed consent (OFSEP)

Exclusion Criteria

• Patients unable to understand the information sheet
• Patients with remittent or active progressive MS
• Patients with a change in the disease-modifying treatment within the previous 3 months
• Patients treated with corticosteroids in the month before inclusion
• Impossibility to provide patients with the necessary information
• Patients in custody
• Patients under guardianship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
validated disability scale (EDSS)	change from baseline validated disability scale at 3 and 12 months
Walking test	change from baseline walking test at 3 and 12 months
Evolution of blood lipid biomarkers	change from baseline evolution of biomarkers at 3 and 12 months

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France