Progressive Multiple Sclerosis Clinical Trial
Official title:
Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis
Background: High dose biotin is a therapeutic option for French progressive Multiple
Sclerosis (MS) patients, without relapse for at least one year, since June 1, 2016. Despite
the inflammatory activity of progressive forms of MS is known to be low, several publications
mentioned clinical and/or radiological activity for biotin-treated patients.
Objectives:
1. To determine if high dose biotin increase the clinical inflammatory activity of patients
with a progressive form of MS.
2. To compare the clinical characteristics of the relapses that occurred with biotin or
not.
3. To describe the characteristics of the patients with a clinical inflammatory activity
with biotin.
Methods: This is a national, academic, observational and retrospective study comparing one
group of progressive MS patients with high dose biotin to another group without this
treatment using a propensity score, in intention to treat. The main judgment criterion is the
annualized relapse rate (ARR) from the beginning of the biotin to the last evaluation
available before the data extraction. A Student's t test will be used. A negative binomial
modelling with relapses counting over a period of exposure and taking into account the inter
and intra center variability will be used. The statistical tests will be adapted to the
nature of the variables concerning the secondary judgment criteria.
Expected results: This French national study will provide a better knowledge of the
inflammatory activity of the progressive forms of MS treated with high dose biotin. If an
increased clinical inflammatory activity is highlighted with biotin a prospective study will
be necessary to confirm the result before a specific information of the scientific community
and the patients about this risk or even an amendment of prescription rules in order to
secure the use of the product. On the contrary, the absence of increased risk of clinical
inflammatory activity with biotin would help to reassure the prescriber and the patient about
the innocuity of the treatment.
Investigators are going to recruit retrospectively all the patients treated with biotin since the product is available in France, in all French MS centers that agree to participate (maximum 30). They are going to collect through medical records, demographic data (as age, gender, MS center localization), but also data about the disease (as MS duration, primary progressive or secondary progressive MS), data about disability (with several Expanded Disability Status Scale -EDSS- scores at different time points) and data about treatments (as duration of biotin, existence of other concomitant disease-modifying therapy). For comparison, a control group without biotin is going also to be recruited from the European Database for Multiple Sclerosis (EDMUS). The same data as described above are going to be collected for the controls. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02282826 -
A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
|
Phase 1 | |
Completed |
NCT02804594 -
A Study of Oxidative Pathways in MS Fatigue
|
Phase 2 | |
Completed |
NCT04120675 -
Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis
|
N/A | |
Completed |
NCT01719159 -
Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
|
Phase 2 | |
Recruiting |
NCT05740722 -
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT03980145 -
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
|
N/A | |
Completed |
NCT03269071 -
Neural Stem Cell Transplantation in Multiple Sclerosis Patients
|
Phase 1 | |
Not yet recruiting |
NCT05811013 -
Effects of Transcranial Static Magnetic Field Stimulation (tSMS) in Progressive Multiple Sclerosis
|
N/A | |
Not yet recruiting |
NCT04289909 -
Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS)
|
N/A | |
Recruiting |
NCT05685784 -
Multiple Sclerosis Prediction and Monitoring of Progression Study
|
N/A | |
Completed |
NCT03493841 -
Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis
|
Phase 1 | |
Completed |
NCT03302806 -
Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
|
||
Recruiting |
NCT05441488 -
Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
|
Phase 3 | |
Recruiting |
NCT04695080 -
ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis
|
Phase 2/Phase 3 | |
Recruiting |
NCT06451159 -
A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis
|
Phase 1 | |
Completed |
NCT03423121 -
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Terminated |
NCT02580669 -
Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis
|
N/A | |
Enrolling by invitation |
NCT05706220 -
Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
|
||
Recruiting |
NCT01815632 -
Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS)
|
Phase 2 | |
Recruiting |
NCT01364246 -
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
|
Phase 1/Phase 2 |