Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
Multiple SclerosisRelapsing-Remitting4 moreThis study will evaluate if giving insulin that is administered in the nostrils (intranasal) is safe and tolerable for people with multiple sclerosis (MS). It is also being done to evaluate if intranasal insulin improves cognitive function in people with MS and to evaluate how it might be working.
Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis
Relapsing Remitting Multiple SclerosisInterleukin-2 (IL-2) was initially discovered and used as a stimulator of effector T lymphocytes (Teffs), but is now viewed as a very promising immunoregulatory drug having the capacity to stimulate regulatory T cells (Tregs). At low dose, Il-2 tips the Treg/Teff balance towards Tregs. Recently, it has been shown that Tregs of MS patients have reduced proliferative potential. MS-IL2 will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis (RRMS), with the aim to stimulate Treg and define potential clinical benefits
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With...
Multiple SclerosisThis study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
Healthy Volunteer Study Using 3 Different Formulations of Firategrast
Multiple SclerosisRelapsing-RemittingThis study will investigate how 3 types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so a proper comparison with the new formulations can be made. The new fomulations will be administered with food and the reference formulation will be given without food. In Part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. Each of these doses will be given with food.
Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis...
Multiple SclerosisMultiple Sclerosis1 moreObjective: The primary goal of this study is to investigate the mechanism of action (MOA) of CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS. Study population: Two cohorts of patients will be enrolled: Long-term daclizumab therapy cohort: Up to 15 daclizumab-treated patients with relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously classified as HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab for a minimum of 1 year and responded to this therapy with significant (>70%) decrease in contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60% decrease in MS relapses and stable or improved EDSS disability score). New treatment cohort: Up to 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic response to first-line, FDA-approved immunomodulatory therapies for MS or who cannot, for any reason, be treated with first-line, FDA-approved immunomodulatory therapies for MS. Design: This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP) administered subcutaneously (SC) every 4 weeks for a total of 3 years. Outcome measures: Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in MS, the primary outcomes are mechanistic immunological studies performed on clinical samples (peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term safety and tolerability of subcutaneous DAC HYP in HI-MS patients.
A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis...
Multiple SclerosisThe objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.
Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients...
Multiple SclerosisThis study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.
A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared...
Multiple SclerosisRelapsing-RemittingIn the course of therapy escalation, the multiple sclerosis (MS) subjects with high activity of disease receive mainly mitoxantrone. The duration of therapy is limited because of a cumulative dose for life (140 mg/m^2 body surface area). In practice lower doses of mitoxantrone (60-120 mg/m^2 body surface area) are being used. The specific reason for this limited total dose are potential cardiotoxic side effects of mitoxantrone. Once this cumulative dose of mitoxantrone is reached and the subject becomes stable, there is the question for subsequent therapy. A possibility at this time, is the so-called "de-escalation", therefore reducing the subject back to immunomodulating basic treatment. The target of this open-label, randomised, multicentric, comparative, parallel-group study was to inquire systematically into the use and course of basic therapy with Rebif 44 mcg thrice weekly (tiw) for a larger number of subjects.
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple...
Multiple SclerosisThis extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing...
Relapsing-Remitting Multiple SclerosisThis study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.