Study of Biomarkers of the Response to Biotine

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Biotine Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

validated disability scale (EDSS)

Time frame: change from baseline validated disability scale at 3 and 12 months
Walking test

Time frame: change from baseline walking test at 3 and 12 months
Evolution of blood lipid biomarkers

Time frame: change from baseline evolution of biomarkers at 3 and 12 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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).

Acronym: BIOMARBIOT

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jul 12, 2017
Registry last updated: Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed