Active clinical trials for "Sclerosis"

The primary aim of this study is to evaluate the impact of titration, analgesics, and 12 month telephone follow-up period from the B.E.T.A nurse program upon adherence to treatment with Betaseron in patients with a first clinical demyelinating event suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12 months Secondary outcomes include analysis of the following parameters: progression of clinical severity by the expanded disability status scale (EDSS score), health related quality of life (HrQoL), and safety. Exploratory outcomes include changes over time in cytokine and neurotrophic factor production by immune cells and visual function as assessed by visual examination, OCT measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire (NEI-VFQ-25) with 10-item supplement.

Phase IV open label, single-blind study, post-marketing, 1-year MRI observational study evaluating effect of Avonex® monotherapy (6.0 MIU administered i.m. each week) on the year-to-year changes in two annual measures-magnetization transfer imaging and diffusion-weighted imaging in patients with either relapsing-remitting (RR) or secondary-progressive (SP) multiple sclerosis (MS). One hundred fifty (150) patients with RR and SP MS-followed at the Jacobs Neurological Institute, University at Buffalo, Buffalo NY-who satisfy both inclusion and exclusion criteria will be included. They will be assessed at baseline and at 12 months with MRI and clinical examinations.

The primary goal of this study will be to explore the reparative and regenerative potential of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies using conventional and non-conventional MRI sequences.

The primary objective of this trial is to observe the Multiple Sclerosis (MS) related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months. The secondary objectives are: To investigate changes in fatigue, capacity for work, Health Related Quality of Life (HRQol), sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking at different times points after initiation of Tysabri treatment in participants diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS). Changes in fatigue are measured at 3, 6 and 9 months, whereas changes in capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking are measured at 6 and 12 months. To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression in participants at baseline, 6 and 12 month of treatment with Tysabri and to document any changes in fatigue related medication.

This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.

This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease - pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study of the REGARD trial. The aim of this trial is to provide additional data on the factors influencing interferon (IFN) beta response. This is a Phase 4 trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected.

This was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects.

The Canadian Multiple Sclerosis Working Group (CMSWG) has developed practical recommendations on how neurologists can assess the status of subjects on disease modifying drugs (DMDs) and decide when it may be necessary to modify treatment in order to optimize outcomes. These recommendations are based on relapses, disease progression as measured by the Expanded Disability Status Scale (EDSS) or EDSS progression, and magnetic resonance imaging (MRI) outcomes. The CMSWG agreed to compare post-treatment relapse rates and severity to baseline rates and severity in each individual subject. The recommended minimum baseline reference time frame needed to assess relapse rate was 2 years prior to treatment initiation. The objective and prospective relapse data should be ideally collected during this reference period. The CMSWG recommended that the following should be taken into consideration when assessing relapse severity: the effect of the relapse on activities of daily living (ADL), the type and number of systems involved (i.e., relapses that are polysymptomatic or that affect the cerebellar/motor systems tend to be more severe), and whether or not a course of corticosteroids was required. The CMSWG also recommended that, prior to considering treatment modification on the basis of progression in disability, progression should be confirmed at 6 months. The CMSWG's Treatment Optimization Recommendations (TORs) have been retrospectively applied to the 4 year data set from the PRISMS study. Applying the model to subjects after their first year on therapy allowed for accurate prediction of continued disease activity in the form of relapses in the majority of subjects who actually experienced ongoing attacks. The model was less effective in predicting disability progression, but this may well have been due to the low numbers of subjects on treatment progressing over the study period. This observational study used the TOR model to identify subjects as either candidates for therapy optimization or as candidates to maintain current therapy. All subjects were then followed prospectively until re- assessment will be done with this model.

The primary objective of this study is to define the effect of Tysabri in patients with relapsing-remitting (RR) multiple sclerosis (MS) over 2 years. The investigators will also explore the extent of remyelination in MS patients treated with Tysabri over 2 years. A secondary objective of this study is to investigate differences in the capacity for remyelination between patients who do or do not respond to Tysabri monotherapy during the same 24 months. A tertiary objective of this study is to monitor Tysabri effect in MS antiphospholipid antibodies positive and MS antiphospholipid antibodies negative patients and to determine perfusion differences according to the antiphospholipid antibodies positivity status.

This study will identify biomarkers (genes and proteins) in patients with relapsing-remitting multiple sclerosis (MS) and link them with clinical disease parameters, such as the extent of inflammation and rate of disease progression, to try to better understand the disease. It will examine how the biomarkers may be related to disease development and progression and differences among patients' symptoms and response to treatment. Patients with relapsing-remitting MS between 18 and 60 years of age who are enrolled in the multi-institutional MS-CombiRx trial may be eligible for this sub-study. Participants have blood tests when they enter the MS-CombiRx study and again after 6 months, 1 year, and 3 years for analysis for genetic and protein analysis.