Active clinical trials for "Multiple Sclerosis"

The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment responders. The secondary objectives of this study are to compare the change in the PCS of the SF-36 between treatment responders and non-responders, to evaluate change from baseline in additional quality of life measures among treatment responders as well as changes from baseline in treatment responders versus non-responders and to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.

Aims of the study: This is a single blind randomized-controlled trial to test the feasibility and the effects of a task oriented training on locomotor function, mobility and balance in multiple sclerosis subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not be treated with a specific physical therapy (usual care). Subjects and methods: 60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic (Azienda Ospedaliero-Universitaria di Ferrara). Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented training (experimental group) or usual care (control group) through a randomization stratification approach, according to a block randomization of 6. The experimental group will receive 10 task-oriented training sessions over 2 weeks (5 sessions/week=intensive training). Three subjects with a supervisor physiotherapist will take part at the TOCT. Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy outcome measures will be clinical test for gait speed (10m walking test), walking endurance (six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); a structured interview for the performance(Lower Extremity Mal); self-assessment questionnaire for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical and psychological impact (multiple sclerosis impact scale MSIS-29), walking ability (multiple sclerosis walking scale MSWS-12). Outcome measures will be assessed the week before the treatment (T0), after the treatment (T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded to the treatment.

Based on favorable preliminary data from ongoing studies testing the safety and tolerability of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life scores as measured by fatigue severity scale score and MS quality of life 54 physical and mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and the diagnosis secondary and primary progressive MS, progressive relapsing MS or relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls diet (modified paleolithic diet) groups will be instructed in completing a daily food log and receive coaching from registered dieticians who are expert in motivational interviewing. The control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and inflammation, blood sugar and insulin levels will be monitored. Additional blood will be frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will be done at baseline and 12 weeks. Outcome measures will be change in quality of life and fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12 weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups will experience more improvements in quality of life and reduced fatigue and in biomarkers than the usual care group experiences at 12 weeks. The usual care group will be given instruction in following both the wahls paleo plus and the wahls diet plans and how to utilize the daily food logs at the end of study visit. The usual care group will receive one nutrition coaching call to assist with implementation of the study diet.

Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect motor pathways and cause muscle weakness. Respiratory complications due to respiratory muscle weakness are common in the terminal stages of MS and contribute to mortality in these patients. Respiratory muscle weakness may also impair the performance of coughing and aspiration, pneumonia, or even acute ventilatory failure may ensue. Functional magnetic stimulation (FMS) is a non-invasive method that promotes the contraction of muscles through nerve activation. Over the last few years, the study investigators have demonstrated efficacy of FMS technology for stimulating respiratory muscles in animal models, able-bodied subjects [3] and spinal cord injured (SCI) patients [4]. In this study, the researchers will investigate the efficacy of using FMS technique for respiratory muscle conditioning in patients with MS. Furthermore, the investigators will also compare expiration related outcomes of FMS technique with resistive expiratory muscle training (REMT) methodology. Hypotheses FMS conditioning of the expiratory muscles can generate significant expiratory flows and pressures in patients with MS. FMS conditioning of expiratory muscles is more effective compared to resistive expiratory muscle training (REMT) in patients with MS.

The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002, Tysabri®) in the study population (Russian participants with relapsing remitting multiple sclerosis). The secondary objectives are to look at evaluation of severity of relapse, hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS), functional tests, quality of life self-assessment questionnaires including the short form health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29 (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.

The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.

The "SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study" is the follow up study of the "SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS)" (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes patients that finish the SWABIMS study for another 12 month with ongoing unchanged medication.

Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults. The management of MS-patients requires treatment with disease-modifying agents, monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good efficacy and is approved for treatment of relapsing MS with a number of restrictions due to safety issues. Cognitive data related to natalizumab treatment are still scarce. Interferon-beta-1b is approved for high-frequency, subcutaneous (sc) administration in the treatment of multiple sclerosis. It reduces the relapse rate, severity, hospitalisation and the disease activity as seen on MRI. This is a pilot study to explore the concept of de-escalating natalizumab treatment to interferon-beta-1b e.o.d compared to continuous treatment with natalizumab in patients with relapsing-remitting multiple sclerosis previously treated with natalizumab for 12 months. The study is designed as prospective, controlled, randomized, rater-blinded, parallel-group, two arm, mono-centric including patients of the Ticino Cohort. One arm will be treated with Interferon-beta 1b 250mcg given subcutaneously every other day, the other with Natalizumab 300 mg given intravenously (i.v.), every four weeks. The treatment duration is 12 months, the follow-up period 12 months. The time to first on-study relapse will be compared between the to treatment arms (primary outcome). Other efficacy parameter include clinical and radiological parameters, patient reported outcome on quality of life and fatigue. Safety is assessed by reports of adverse events.

Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with relapsing forms of multiple sclerosis. This will be an open label upward dose titration involving injections on 9 occasions, each two weeks apart. After dosing is complete there will be a 22 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections and MRI scans will be performed on several occasions to follow the course of the multiple sclerosis during the trial.

Balance impairment is a common and very disabling disturbance in people with Multiple Sclerosis. The efficacy of pharmacotherapy in treating balance impairment in MS is poorly documented in literature. Although literature dealing with the rehabilitation of balance impairment in MS is very scant, the preliminary data reports show very promising results. The present project could have a positive impact on balance and gait ability, disability, fear of falling, risk of falls and quality of life of patients with Multiple Sclerosis.