Shepherd Center - A Catastrophic Care Hospital

An open-label extension study of the double-blind, randomized, parallel group, multi-center phase II study 307000A to further evaluate the safety and tolerability of betaseron 500 mcg subcutaneously every other day and betaseron 250 mcg subcutaneously every other day in patients with relapsing-remitting multiple sclerosis (RRMS). (276)

Principal Investigator: Ben Thrower, MD

Click here for more information about this study in the Research News section of The Synapse newsletter

A phase II/III, randomized double-blind, parallel-group, placebo-controlled multicenter study to evaluate the safety and efficacy of Rituximab (MabThera®/RITUXAN®) in adults with Primary Progressive Multiple Sclerosis – Protocol U2786g (321)

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Principal Investigator: Ben Thrower, MD

A randomized, bouble-blind, placebo-controlled, dose-titration, study to assess the safety, tolerability, and efficacy of C105 in persons with Multiple Sclerosis with cognitive impairment. (405)

Principle Investigator: Ben Thrower, MD

A multi-center, single arm, open-label, phase III study to evaluate the safety and antigenicity of Rebif (IFN Beta-1a) in patients with relapsing forms of Multiple Sclerosis (340)

Principal Investigator: Ben Thrower, MD

A multicenter, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin™ in subjects with Clinically Isolated Syndrome or Relapsing-Remitting Multiple Sclerosis (390)

Principal Investigator: Ben Thrower, MD

A Randomized, Controlled, Open-Label Parallel Group Study to Evaluate the Effect of Regularly Scheduled Neutralizing Antibody Testing on Treatment Patterns versus Usual Care in High-Dose Interferon Treated Subjects (392)

Principal Investigator: Ben Thrower, MD

A randomized, single crossover, single-blind safety and tolerability comparison of disposable auto injector device vs. the prefilled syringe and the autoject 2 for glass syringe when used to self-administer glatiramer acetate (Copaxone)

Principal Investigator: Ben Thrower, MD

A multi-centered, randomized, double-blind, placebo-controlled study assessing the add-on effect of oral steroids in Relapsing Remitting Multiple Sclerosis subjects treated with Glatiramer Acetate (GA)

Study Description: The primary objective of this study is to determine whether glatiramer acetate (Copaxone) and the add-on treatment of prednisone is safe and more effective than the treatment with glatiramer acetate and placebo in subjects diagnosed with the relapsing form of Multiple Sclerosis.

Principal Investigator: Ben Thrower, MD

A double-blind, placebo controlled multi-center study to evaluate the efficacy and safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis

Study Description: The purpose of this study is to evaluate the safety and effectiveness of MBP8298 when compared to placebo in patients with secondary progressive MS. MBP8298 may delay the worsening of disability in subjects with SPMS. MBP8298 or placebo is administered intravenously every 6 months for 24 months for a total of 4 doses.

Principal Investigator: Ben Thrower, MD

Open-label, multicenter, observational, phase IV study to evaluate the adherence to treatment with 250mcg (8MIU) IFNB-1b (Betaseron®) given subcutaneous every other day over a period of up to 12 months in patients with a first clinical demyelinating event suggestive of multiple sclerosis and patients with onset of relapsing-remitting multiple sclerosis (RRMS) within the past 12 months

Study Description: This study is going to evaluate the impact of titration, analgesics, and a nurse follow-up program on adherence to treatment with Betaseron. The B.E.T.A. nurse program includes field and telephone nurses who provide support to MS patients, including distribution of literature and supplies, training in self-administration of Betaseron, reimbursement assistance, follow-up support to patients, and access to informational websites, web casts and telecoms.

Principal Investigator: Ben Thrower, MD

Brain MRI Use As A surrogate Marker In Routine Clinical Practice: A Retrospective Analysis

Study Description: The objective of this study is to determine the frequency of MRI changes on routine follow up MRIs, to determine the utility of screening MRIs for patients with MS on an annual basis. This study will also determine if changes on MRI lead to changes in therapy. Studies show that MRI findings are predictive of disease progression and new MRI lesions may be associated with inadequate therapeutic response.

Principal Investigator: Ben Thrower, MD

Implantable Systems Performance Registry (ISPR)

Principal Investigator: Ben Thrower, MD

Study Description: The purpose of this registry is to monitor the use and performance of Medtronic products and to better understand patient needs. Medtronic will use the information from this registry to improve its products or develop possible new products and therapies. Medtronic will also use the information to follow government regulations regarding product monitoring and safety. Information collected in the registry will be maintained indefinitely.