Study of Biomarkers of the Response to Biotine

Multiple Sclerosis Clinical Trial

— BIOMARBIOT  

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215433
• Other study ID #: MOREAU MedDay 2016
• Status: Completed
• Start date: December 8, 2016
• Est. completion date: January 23, 2019

Study information

• Verified date: September 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 23, 2019
• Est. primary completion date: January 23, 2019
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Biotine
• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	validated disability scale (EDSS)		change from baseline validated disability scale at 3 and 12 months
Primary	Walking test		change from baseline walking test at 3 and 12 months
Primary	Evolution of blood lipid biomarkers		change from baseline evolution of biomarkers at 3 and 12 months