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CompletedNCT03215433BIOMARBIOTUpdated Sep 18, 2019

Study of Biomarkers of the Response to Biotine

An observational study in Multiple Sclerosis and Biotine, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-18.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 65 Years
Sex
All
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Study 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).

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Conditions studied

  • Multiple Sclerosis
  • Biotine

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03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's enrollment of 25 is below the median of 100 across 1,034 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

25 patients with progressive (primary or secondary) MS will be encountered over time during consultations at Dijon CHU. Treatment with biotine will be proposed to patients and a nominative TAU will be requested.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. validated disability scale (EDSS)

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

  2. Walking test

    Time frame: change from baseline walking test at 3 and 12 months

  3. Evolution of blood lipid biomarkers

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

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Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03215433
Responsible party
Sponsor
First posted
Jul 12, 2017
Start date
Dec 8, 2016
Primary completion
Jan 23, 2019
Completion
Jan 23, 2019
Last update
Sep 18, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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