NCT03215433

Study of Biomarkers of the Response to Biotine

Single-centre, Observational Study, Concerning Blood-lipid Biomarkers of the Response to Treatment With Biotine, Prescribed in the Context of a Nominative TAU (Temporary Authorized Use) in Patients With an Inactive Progressive Form of Multiple Sclerosis (MS).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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).

Conditions

• Multiple Sclerosis
• Biotine

Timeline

• Start date: 2016-12-08
• Primary completion: 2019-01-23
• Completion: 2019-01-23
• First posted: 2017-07-12
• Last updated: 2019-09-18

Locations

1 site across 1 country: France