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Multiple Sclerosis Clinical Trials

Robert S. Tillett Jr., M.D., the neurologist in charge of clinical research studies for multiple sclerosis (MS) at Norton Neuroscience Institute, says these are exciting days in the treatment of this autoimmune disease. And he says MS patients in Greater Louisville are the ones who’ll benefit.

For more information about our MS trials, call (502) 899-6782 or email neuro_research@nortonhealthcare.org

Clinical Trials


Title: A 12-month, randomized, rater- and dose-blinded study to compare the efficacy and safety of fingolimod 0.25 mg and 0.5 mg administered orally once daily with glatiramer acetate 20 mg administered subcutaneously once daily in patients with relapsing-remitting multiple sclerosis

Sponsor: Novartis Pharmaceuticals Corp

Principal Investigator: Robert S. Tillett Jr., M.D., MSCS

Purpose: The main purpose of this study is to compare 2 doses of fingolimod (0.25 mg and 0.5 mg) with glatiramer acetate 20 mg and to evaluate the effectiveness and safety of fingolimod 0.25 mg for people with RRMS.  


Title: MS Spasticity: A Placebo-Controlled, Randomized Withdrawal Evaluation of the Efficacy and Safety of Extended Release Baclofen Capsules in Subjects with Spasticity due to Multiple Sclerosis

Sponsor: Sun Pharma Advanced Research Company (SPARC)

Principal Investigator: Robert S. Tillett Jr., M.D., MSCS

Purpose: Study of patients age 18 and older who have spasticity on a stable dose of Baclofen. Patients who qualify for this 21 week study may receive an extended release version of Baclofen to assess effectiveness. Study participants continue their disease modifying therapy and receive study related medication, lab and evaluations by an MS specialist. Compensation is provided for time and travel.

Contact: Diana Godwin, R.N., (502) 899-6732


Title: Relapsing MS: JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri®: STRATIFY-2

Sponsor: Biogen Idec Inc.

Physician Investigator(s): Robert S. Tillett Jr., M.D., MS certified specialist

Purpose: The purpose of STRATIFY-2 is to better understand whether antibodies to JCV may be used to predict whether a patient is at higher or lower risk for developing PML.


Title: Progressive Multifocal Leukoencephalopathy: Genetic Evaluation of Natalizumab-Treated Patients with Progressive Multifocal Leukoencephalopathy (PML)

Sponsor: Biogen Idec Inc.

Physician Investigator(s): Robert S. Tillett Jr., M.D., MS certified specialist

Purpose: The purpose of this study is to look for genetic differences that may make some patients more likely to get PML.


Title: MS treated with Tysabri: TYGRIS: Tysabri Global Observational Program in Safety

Sponsor: Biogen Idec

Principal Investigator: Robert S. Tillett Jr., M.D., MS certified specialist

Purpose: The purpose of TYGRIS is to collect information on serious infections, cancers, and other serious side effects that may occur in subjects with multiple sclerosis (MS) treated with TYSABRI®.


Title: Relapsing-Remitting MS: A Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults with Relapsing-remitting Multiple Sclerosis

Sponsor: National Institute of Allergy & Infectious Disease

Principal Investigator: Robert S. Tillett Jr., M.D., MS certified specialist

Purpose: The purpose of this study is to find out if the experimental drug, Abatacept can help improve MS as shown by better MRI results in subjects treated with Abatacept.  Another purpose of the study is to find out if Abatacept is safe to use in subjects with MS.


Title: Relapsing- Remitting Multiple Sclerosis: FTY720D2403 - Long-term, prospective, observational, multinational, parallel-cohort study monitoring safety in patients with MS newly started with fingolimod once daily or treated with another approved disease-modifying therapy

Sponsor: Novartis Pharmaceuticals Corp.

Principal Investigator: Robert S. Tillett Jr., M.D., MS certified specialist

Purpose: The main purpose of this study in subjects with MS, either newly prescribed GILENYA or receiving another approved medication, is to evaluate long-term safety of GILENYA and further explore the incidence of selected safety outcomes.


Title: Relapsing- Remitting Multiple Sclerosis: A Multicenter, Observational, Open Label, Single Arm Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

Sponsor: Quintiles

Principal Investigator: Robert S. Tillett Jr., M.D., MS certified specialist

Purpose: The purpose of the study is to find out if there are any assessments that might predict whether or not patients receiving Tysabri will remain free of disease (that is, without relapses, worsened disability, and/or lesions on brain magnetic imaging [MRI] scans) and how effective Tysabri is at keeping patients who are in the early stages of MS free of disease. 


Title: MS Spasticity: A clinical evaluation of the safety of Baclofen ER Capsules (GRS) when administered once daily to subjects with spacticity due to Multiple Sclerosis (MS): An open label, long term, safety trial.

Sponsor: Sun Pharma Advanced Research Company (SPARC)

Principal Investigator: Robert S. Tillett Jr., M.D., MS certified specialist

Purpose: The purpose of this research study is to gather scientific information about the long-term safety of the investigational new drug, SPARC’s Baclofen ER Capsules (Gastro-Retentive System [GRS]) in subjects with spasticity due to MS. Extended release (ER) medication may allow you to take a medication fewer times in a single day.


 

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