Clinical Trials Logo

Clinical Trial Summary

Multiple sclerosis (MS) is a common cause of severe neurological disability in young adults, resulting from an autoimmune interruption of both myelin and axons within the central nervous system (CNS). The diagnosis is made by fulfilling both spatial criteria, by meeting the requisite number of lesions within the brain or spinal cord, along with criteria for time, by demonstrating a history of at least a second clinical attack or the development of a new MS lesion on MRI after the seminal neurological event. In the case of MS, healthy individuals who do not exhibit signs of neurological dysfunction commonly have brain MRI studies performed for a reason other than an evaluation for MS that reveal unexpected anomalies highly suggestive of demyelinating plaques given their size, location, and morphology. These healthy subjects lack symptomatology suggestive of MS and fulfill formal criteria for radiologically isolated syndrome (RIS), a recently described MS subtype that expands upon the phenotype of at-risk individuals for future demyelinating events. The discovery of such anomalies creates intersecting neuro-ethical, legal, social, and practical medical management quandaries and is, therefore, of both immediate and long-term clinical significance. Despite advancements in the characterization of RIS subjects, and in our understanding of risk factors for initial symptom development, the effect of treatment on such cases remain unclear.

The purpose of this investigation is to systematically study the efficacy of Teriflunomide in those individuals who possess incidental white matter anomalies within the brain and following a MRI study that is performed for a reason other than for the evaluation of MS.

RIS subjects are frequently exposed to disease modifying therapies despite the lack of scientific literature supporting the use of such treatments. Earlier treatment intervention may extend the time to the first acute or progressive clinical event resulting from CNS demyelination and reduce radiological progression. In addition, early treatment may result in more profound effects on reducing disability progression long-term.

The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination.

This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03122652
Study type Interventional
Source Centre Hospitalier Universitaire de Nice
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 25, 2017
Completion date October 24, 2022

See also
  Status Clinical Trial Phase
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Recruiting NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Active, not recruiting NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4
Completed NCT02232061 - Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks Phase 4
Recruiting NCT03983681 - Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS N/A
Enrolling by invitation NCT04676204 - Relationship Between Oral DMT Burden and Adherence in MS
Recruiting NCT03424733 - Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects Phase 4
Completed NCT03326505 - Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment Phase 1/Phase 2
Active, not recruiting NCT03396822 - Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis
Completed NCT04035889 - Melatonin for Sleep in MS N/A
Recruiting NCT03854123 - Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics
Active, not recruiting NCT03355365 - Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis Phase 2