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Critical Demyelinating Lesions as a Cause of Progressive Motor Deterioration
Rochester, Minn.
The purpose of this study is a comprehensive review of the clinical and radiologic history in these patients as well as review of neuropathology in deceased patients, where available. The goal of this research is to investigate the hypothesis that this presentation represents a spatially limited form of CNS inflammatory demyelinating disease.
Closed for Enrollment
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A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI) (BEAT-MS)
Rochester, Minn.
The purpose of this trial is to compare the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
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A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants with Nonrelapsing Secondary Progressive Multiple Sclerosis (HERCULES) (HERCULES)
Rochester, Minn.
This study aims to determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS and on clinical endpoints, MRI lesions, cognitive performance, physical function, and quality of life.
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A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS) (PERSEUS)
Rochester, Minn.
The primary objectgive of this study is to determine the effectiveness of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS).
The secondare objectives are to evaluate the effectiveness of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life; to evaluate safety and tolerability of SAR442168; to evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to effectivness and safety; and to evaluate pharmacodynamics of SAR442168.
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Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients with Multiple Sclerosis and Walking Impairment
Rochester, Minn.
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher plasma amantadine concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to deliver its primary treatment effect during the day, and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep.
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