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Multiple Sclerosis clinical trials

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NCT ID: NCT03917589 Completed - Multiple Sclerosis Clinical Trials

Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS Patients (COPP-MS)

COPP-MS
Start date: June 20, 2019
Phase:
Study type: Observational

Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum (PP) period is a critical phase in MS patients, during which a recrudescence of disease activity is expected. Different strategies have been assessed in the prevention of post-partum relapse. High dose methylprednisolone was evaluated in a case control study with historical controls but the positive results have not been confirmed. In this study, the main objective will be to compare the risk of relapse in the 6 months PP period between patients treated systematically by high dose methylprednisolone after delivery compared to patients who didn't receive a systematic treatment. The second objective will be focused on the comparison of the disease activity and disability progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery vs patients who haven't.

NCT ID: NCT03915028 Recruiting - Multiple Sclerosis Clinical Trials

Thermal Cures in the Treatment of Multiple Sclerosis

SPA-SEP
Start date: May 23, 2019
Phase: N/A
Study type: Interventional

Multiple Sclerosis (MS) is a chronic, progressive disease with a high prevalence in France, with significant public health consequences. The benefit of spa treatments on the quality of life in this population has not been evaluated. The methods of study in clinical pharmacology can be a scientific methodological model for the evaluation of thermal practices and it is in this perspective that investigators want to lead this project.

NCT ID: NCT03910738 Recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis

TOTEM-RRMS
Start date: October 29, 2019
Phase: Phase 2
Study type: Interventional

Centra nervous system (CNF) damage in multiple sclerosis (MS), are mainly attributed to myelin destruction, axonal abnormalities and subsequent degeneration, and are responsible for serious deficiencies. Current therapies are focused on the treatment of inflammation with several types of anti-inflammatory agents. However, there is an urgent need for innovative therapies promoting neuroregeneration and particularly myelin repair. It has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial. The main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes. As secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work / activity and anxiety / depression).

NCT ID: NCT03906370 Completed - Multiple Sclerosis Clinical Trials

Capillary Dysfunction and CD46-immunoreceptor (CD46) Type in MS

Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

This project aims to contribute knowledge to early MS disease mechanisms at the brain-blood interface using a combined immunological and neuroimaging approach. The aim is to provide a novel vascular model to assess MS disease activity, and to explore its potential as an early diagnostic biomarker, prior to blood-brain barrier disruption. Additionally, the investigators want to investigate influence of immune receptor defects upon disease activity and MS brain vascular system. These aims are addressed by investigating immune receptor signals and vascular imaging modalities acquired in newly diagnosed untreated MS cohort, followed at our institution.

NCT ID: NCT03900221 Recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorder

French Registry for Monitoring Pregnancies for Multiple Sclerosis

RESPONSE
Start date: August 12, 2019
Phase:
Study type: Observational [Patient Registry]

The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia. To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)

NCT ID: NCT03896217 Completed - Clinical trials for Secondary Progressive Multiple Sclerosis

Simvastatin in Secondary Progressive Multiple Sclerosis

MS-OPT
Start date: May 16, 2019
Phase: Phase 2
Study type: Interventional

Multiple sclerosis (MS) is a neurological condition which is a common cause of disability in young people. It is thought to be an autoimmune condition, where the body's immune system begins to attack itself. The cause of MS is unknown but is thought to be a mix of genetic and environmental factors. There are treatments available for early stages of MS, but the later stage known as Secondary Progressive MS (SPMS) has no current treatment. Statins are a safe treatment traditionally used to reduce cholesterol levels. However, statins also have other effects which could reduce the progression of SPMS, such as effects on the immune system and circulation. A recent study (Chataway et al., 2014) showed that treatment with high-dose simvastatin, a type of statin, reduced the progression of SPMS but no effect on the immune system was seen. It is possible that simvastatin does not treat the immune system but improves how the blood and blood vessels in the brain work in this disease. The purpose of the clinical trial is to test how Simvastatin (80mg/day) may slow down disease progression in people living with SPMS compared to placebo (dummy pill). Participants will receive either Simvastatin or placebo and will be asked to take 2 tablets daily, for up to 17 weeks.

NCT ID: NCT03893344 Completed - Multiple Sclerosis Clinical Trials

STAT4 in Multiple Sclerosis by PCR and Flow Cytometry

Start date: September 20, 2019
Phase:
Study type: Observational

1. To determine the level of STAT4 expression in different cases of multiple sclerosis and its relation to disease severity . 2. compare the sensitivity and specificity of STAT4 levels using both PCR and flow cytometry.

NCT ID: NCT03889639 Completed - Clinical trials for Relapsing Multiple Sclerosis

Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

Start date: March 29, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary Objectives: - To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures. - To evaluate the safety and tolerability of SAR442168.

NCT ID: NCT03889327 Completed - Multiple Sclerosis Clinical Trials

Intervention to Reduce Perceived Cognitive Impairment in Multiple Sclerosis

Start date: March 26, 2018
Phase: N/A
Study type: Interventional

Multiple sclerosis (MS) is among the most prevalent autoimmune diseases among young and middle-aged adults. Up to 65% of MS patients experience objective cognitive impairment including problems with information processing speed, memory, and executive functioning. However, patients commonly overestimate the extent of their cognitive dysfunction which can result in inaccurate perceptions of their true cognitive abilities. Exaggerated perceptions of cognitive impairment are predictive of future decline and associated with depression, anxiety, and reduced quality of life. Despite this, no study has examined an intervention aimed at changing misperceptions related to perceived cognitive impairment in MS when objective measures are incongruent with self-reported cognitive symptoms. The purpose of the present study is to develop and pilot a brief intervention for MS patients who perceive cognitive impairment, but perform in the normal or expected range on objective measures of cognition.

NCT ID: NCT03888924 Recruiting - Multiple Sclerosis Clinical Trials

Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)

Start date: June 17, 2019
Phase: Phase 2
Study type: Interventional

Multiple sclerosis (MS) witnessed relevant therapeutic progress in the last decade. Following the extraordinary progress in the treatment of relapsing-remitting (RR) multiple sclerosis (MS), two major unmet needs remain to be addressed by translational research in this field: progressive MS and the "dream" of a world free of MS. As far as the latter is concerned, the investigators can hope to make the dream come true by understanding the etiology of the disease and hence design definitive cures. A more realistic and pragmatic perspective may be the prevention of the clinical onset of the disease, a research field that promises to become increasingly important as the integration of genetic data with endophenotypes, magnetic resonance imaging and other biomarkers ameliorates the ability to predict the development of the disease under clinical circumstance. Bacille Calmette-Guerin (BCG) vaccine has been tested with encouraging results in early MS and clinically isolated syndrome (CIS). The knowledge that disease-modifying therapies work best when used early in the demyelinating process raises the question about whether to try this approach - which is safe, cheap and handy - in individuals with radiologically isolated syndrome (RIS). Radiologically isolated syndrome is a new entity, diagnosed when the unanticipated magnetic resonance imaging (MRI) finding of brain spatial dissemination of focal white matter (WM) lesions highly suggestive of MS occurs in subjects without symptoms of MS, and with normal neurological examinations. Conversion to clinically isolated syndromes (CIS) were described in 84% of RIS individuals with spinal cord lesions over a median time of 1.6 years from the date of the first MRI. Whether or not to treat this condition remains currently a clinical conundrum. Bacille Calmette-Guérin (BCG) vaccine may have these characteristics since it resulted beneficial in early MS and first demyelinating episodes. Being safe, cheap and handy, the investigators propose to investigate its use to prevent progression of the demyelinating process in radiologically isolated syndrome. An approach such as BCG vaccine seems appropriate as a front-line immunomodulatory approach for RIS people. In a pilot study BCG vaccine was safe and effective in reducing disease activity at MRI, and the risk of developing persistent T1-hypointense lesions ('black holes' -BH- expression of tissue damage) in subjects with MS.