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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03215433

Acronym

BIOMARBIOT

Enrollment

Registered

2017-07-12

Start date

2016-12-08

Completion date

2019-01-23

Last updated

2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biotine, Multiple Sclerosis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results