Multiple SclerosisBIOMARBIOTNCT03215433
Study of Biomarkers of the Response to Biotine
An observational study of Multiple Sclerosis and Biotine, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Biotine
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2016to 23 Jan 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
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).
- Conditions
- Multiple Sclerosis, Biotine
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
validated disability scale (EDSS)
Measured: change from baseline validated disability scale at 3 and 12 months
Walking test
Measured: change from baseline walking test at 3 and 12 months
Evolution of blood lipid biomarkers
Measured: change from baseline evolution of biomarkers at 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start8 Dec 2016
- Primary completion23 Jan 2019
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215433
- Sponsor's protocol ID
- MOREAU MedDay 2016
- Acronym
- BIOMARBIOT
- Status last verified
- Sep 2019
- First submitted
- 26 Jun 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03215433
- Acronym / sponsor ID
- BIOMARBIOT / MOREAU MedDay 2016
- Conditions
- Multiple Sclerosis, Biotine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Biotine, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validated disability scale (EDSS) (time frame: change from baseline validated disability scale at 3 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.