A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple...
Progressive Multiple SclerosisPrimary Objective: To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients with progressive multiple sclerosis. Secondary Objectives: To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis. To characterize the safety and tolerability of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple...
Multiple Sclerosis (MS)The purpose of this study is to evaluate the clinical efficacy and the optimal way of administration of autologous mesenchymal bone marrow stem cells (MSC) compering intravenous injection and intrathecal injection vs. placebo, in active-progressive Multiple Sclerosis patients.
A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple...
Progressive Multiple SclerosisPrimary Objective: To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and subcutaneous (SC) doses in men and women with progressive multiple sclerosis. Secondary Objectives: To assess the following in men and women with progressive multiple sclerosis: The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses. The pharmacodynamics (PD) of GZ402668 after ascending single IV doses. The PK parameters of GZ402668 after ascending single SC doses. The PD of GZ402668 after ascending single SC doses.
A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants...
Multiple SclerosisRemittent Progressive5 moreThis is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled parallel-group period, and Part B and C are open-label extension periods. The primary objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind portion of the study is to evaluate the safety and tolerability of prolonged-release Fampridine in this study population. The primary objective of the open-label extension study (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The primary objective of the additional open-label extension (Part C) is to provide participants who complete the study with continued access to prolonged-release fampridine until marketed drug can be used at the applicable site or until sponsor decision to discontinue the study.
Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
Multiple SclerosisSecondary Progressive4 moreThe purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.
Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)
Primary Progressive Multiple SclerosisBackground: Multiple sclerosis (MS) is an inflammatory disorder of the central nervous system that progressively weakens and destroys the pathways of the nervous system. About 10 percent to 15 percent of patients develop primary-progressive MS (PP-MS), characterized by progressive accumulation of disability from the disease onset, without any marked improvements or relapses. There are currently no effective treatments for PP-MS. Idebenone is a manmade drug that is similar to a naturally occurring compound known as coenzyme Q10, a common dietary supplement. Research data suggest that idebenone may be able to limit demyelination and death of brain cells and thereby slow or halt the progression of neurological dysfunction such as that occurring in MS. Objectives: - To evaluate the safety and effectiveness of using idebenone to treat primary progressive MS. Eligibility: - Individuals between 18 and 65 years of age who have been diagnosed with primary progressive multiple sclerosis. Design: The study will last 3 years and will be divided into two parts: a 1-year pretreatment baseline and 2 years of treatment with either idebenone or a placebo. Pre-treatment study: approximately 5 clinic visits over 1 year. Visit 1: Comprehensive medical history and neurological examination, with brain scans and neurological tests. Visit 2: Magnetic resonance imaging (MRI) scan of the spine and lymphocytapheresis (withdrawal of white blood cells for testing). Visit 3: Lumbar puncture. Visit 4: Skin biopsy. Visit 5: Repeat MRI of the brain and spinal cord, as well as neurological tests; these tests will be scheduled over 2 days. After the five pretreatment visits, patients will receive a 6-month supply of study medication (either idebenone or a placebo) to take three times a day with food Patients will continue to have regular followup clinic visits with brain MRI scans, blood tests, and other evaluations of brain and nervous system function. Randomly selected participants will have additional MRI scans for further safety precautions.
Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple...
Autoimmune DiseasesImmune System Diseases5 moreThe main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.
A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple...
Multiple SclerosisThis is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.
Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple SclerosisThe purpose of this study is to determine whether MIS416 administered once weekly over 12 months is safe, tolerable, and improves a range of signs and symptoms associated with secondary progressive multiple sclerosis.
A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS
Secondary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisThe purpose of this study is to examine the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT). Fampridine has been shown to be effective in improving motor function, specifically walking ability in prior studies in this patient population and is currently licensed for this use in Europe and the United States. Upper limb dysfunction is common in SPMS and PPMS and often underestimated. Fampridine effects action potential conduction in demyelinated nerve fibres and we would hypothesise that the improvement previously reported in walking ability would be similar to that on upper limb dysfunction. Our study aims to address this question using both independent and patient reported outcomes in the context of a randomised placebo controlled crossover trial.