Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis...
Relapsing-remitting Multiple SclerosisMultiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults affecting approximately 1 in 1.000 people in western countries. The clinical manifestations usually begin at the age of 20 to 40 years with a median age of 28 years at onset with acute episodes of neurological dysfunction, followed by periods of partial or complete remission and clinical stability in between relapses. This relapsing-remitting phase (RR-MS) of the disease is usually followed by progressive clinical disability (secondary progressive phase, SP-MS). At present, there is no cure for MS. Based on the pathological concept that neuroinflammation is the common element leading or contributing to neurodegenerative changes, immune interventions have been introduced into clinical practice such as Natalizumab (Tysabri), a humanized monoclonal antibody. Natalizumab (Tysabri) is indicated as a disease-modifying monotherapy of highly active relapsing MS. The associated risks, especially progressive multifocal leukoencephalopathy, necessitate active monitoring of patients and a continuous discussion of optimum use of this drug. In clinical practice, the question how to manage patients on natalizumab at a higher risk for progressive multifocal leukoencephalopathy remains unresolved. This prospective, controlled (comparison to the period prior to natalizumab treatment), single-arm, open-label, multi-centre, phase IV study aims to evaluating the concept of natalizumab de-escalation to interferon-beta-1b e.o.d in relapsing-remitting multiple sclerosis patients, who consider stopping natalizumab due to a benefit-risk assessment. In particular, to evaluating if interferon beta-1b treatment may be able to overcome the recurrence of significant clinical and radiological disease activity after natalizumab cessation and may keep disease activity better under control as compared to the time prior to natalizumab. The study population includes patients with relapsing-remitting multiple sclerosis (RR-MS) being treated at least for 12 months with natalizumab and having decided to stop natalizumab treatment and to de-escalate their therapy to a first line treatment with interferon beta-1b. They will be treated during 12 months with interferon-beta 1b 250 mcg given subcutaneously every other day. A 12-month follow-up period with the same treatment is planned.
A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis...
Relapsing-remitting Multiple Sclerosis (RRMS)The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.
Light Therapy as Treatment for Fatigue in Multiple Sclerosis
Multiple SclerosisRelapsing-RemittingThis prospective study will randomize 1:1 people living with multiple sclerosis-associated fatigue to one of two spectra of light therapy. Each participant will be asked to use the light box twice daily at home or at the workplace at preset hours during the day for a total of four weeks. Participants will be asked to record their fatigue on standard measurement scales before, during, and after the use of the light therapy box. The investigators anticipate a reduction in self-reported fatigue following the use of the light box therapy of a particular spectrum of light among people living with multiple sclerosis.
Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis...
Relapsing-remitting Multiple SclerosisThe objective of the clinical study of the medicinal product for medical use: to compare efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis. Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to March 23, 2016. Number of patients, involved into the study of the medicinal product for medical use: 158 patients.
RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.
Multiple SclerosisRelapsing-RemittingA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
Multiple SclerosisThe primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.
Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With...
Multiple SclerosisRelapsing-RemittingThe primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.
Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients...
Multiple SclerosisThis study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in patients with Relapsing-Remitting Multiple Sclerosis.
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have...
Multiple SclerosisRelapsing-RemittingThe purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.
Wireless, Implantable Tibial Nerve Stimulator System for the Treatment of Refractory Lower Urinary...
Multiple SclerosisRelapsing-RemittingPrevalence of lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (MS) increases with disease duration. Current management of urinary clinical symptoms in MS is mainly conservative. Its long-term outcome is often poor because of the progressive disease course and the treatment related side effects. Alternative therapeutic options are botulinum toxin injections, electrical stimulation of dorsal penile/clitoral nerve, and sacral nerve modulation. Posterior tibial nerve stimulation (PTNS) is a second minimally invasive method of electrical stimulation. Multiple benefits may derive from the development and validation of a dedicated protocol of a new self-activated neuromodulation therapy, which may improve therapy compliance/effectiveness, quality of life and social life in MS patients with refractory LUTS. Furthermore, it may contribute to reduce outpatient visits, health costs and work absenteeism.