Study of Biomarkers of the Response to Biotine

NCT ID: NCT03215433

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-08

Study Completion Date

2019-01-23

Brief Summary

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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

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Conditions

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Multiple Sclerosis Biotine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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MOREAU MedDay 2016

Identifier Type: -

Identifier Source: org_study_id

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