research

Clinical Studies

UW Health Neurologists are engaged in clinical research in areas including:

• amyotrophic lateral sclerosis (ALS) and other neuromuscular diseases
• stroke
• epilepsy
• parkinson disease
• multiple sclerosis
• the effects on neurological diseases on cognition and memory
• painful diabetic neuropathy
• Parkinson's disease
• pain and reflex sympathetic dystrophy

Neurology Clinical Studies

MULTIPLE SCLEROSIS

Title: Novartis CFTY720D2309
PI: John Fleming, MD
Sponsor: Novartis Pharmaceuticals Corporation

This study is a 24-month, randomized, multicenter, double-blind, placebo-controlled, parallel-group study for patients with Relapsing Remitting Multiple Sclerosis. The study consists of two Phases: a Pre-Randomization Phase (lasting for up to 45 days), and a Double-blind Treatment Phase (lasting for up to 24 months). The purpose of this study is to evaluate how safe and effective an oral investigational medication is in reducing the number of relapses in patients with relapsing-remitting MS treated for a longer time i.e. up to 2 years. This study is closed to enrollment. The subjects currently enrolled in the core study will have the option of participating in an open-label extension study.

Title: Biogen 109-MS-302
PI: Christopher Luzzio, MD
Sponsor: Biogen Idec

The study involves 25 visits over 2 years time and is for people age 18 to 55 years who have Relapsing Remitting Multiple Sclerosis. The study seeks to find out if the study drug (BG00012) is effective in reducing the rate of clinical relapses at 2 years in comparison to a placebo and a comparator drug (Copaxone). The study drug is a pill that may affect the body’s immune system in a way that helps the body’s defense against stress and inflammation. This study is no longer enrolling. At conclusion of this study subjects will be allowed to enroll in a new extension study that will compare two different doses of the study drug BG00012.

Title: Helminth-induced immunomodulation therapy (HINT Phase 2)
PI: John Fleming, MD
Sponsor: National Multiple Sclerosis Society

This study is anticipated to begin in September 2009. Fifteen patients newly diagnosed Relapsing-Remitting Multiple Sclerosis and treatment naïve will be recruited. The study will evaluate safety, tolerability and effectiveness of the Helminth-induced immunomodulation therapy (HINT) in patients with relapsing-remitting multiple sclerosis (RRMS). The primary outcome measure will be MS activity, as judged by the number of new gadolinium-enhancing (n-gd+) lesions on serial MRI scans. Secondary outcomes will include immunological assessments on serum and peripheral blood mononuclear cells; and changes in MS clinical status. 

Title: Novartis CFTY720D2306
PI: Christopher Luzzio, MD
Sponsor: Novartis Pharmaceuticals Corporation

This study is anticipated to begin in October 2009. The purpose of this study is to evaluate the safety and tolerability as well as the effectiveness of an investigational oral medication in delaying disability progression in patients with Primary Progressive Multiple Sclerosis. The study will consist of a pre-treatment phase and a 3 year treatment phase. 

EPILEPSY

Title: NP10005 RNS LTT: RNS System Long-term Treatment Clinical Investigation
PI: Paul Rutecki, MD
Sponsor: Neuropace, Inc

The RNS System Pivotal Clinical Investigation is designed to determine whether the Responsive Neurostimulator (RNS) system is safe and is effective as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications. This study is no longer enrolling but continues to have active participants.

Title: DN 1008934: Responsive Neurostimulator (RNS) System Pivotal-A Clinical Investigation
PI: Paul Rutecki, MD
Sponsor: Neuropace, Inc

This is a randomized, double-blinded, multi-center, sham-controlled clinical investigation. The study contains five distinct time periods. The first period is the Baseline Period (12 weeks minimum, 60 weeks maximum), followed by the Post-operative Stabilization Period (4 weeks), Stimulation Optimization Period (4 weeks), Blinded Evaluation Period (12 weeks), and the Open Label Evaluation Period (84 weeks). Subjects participate in the RNS System Pivotal Clinical Investigation for a minimum of 116 weeks to a maximum of 164 weeks. Participants currently enrolled have the option of continuing into the extension phase of the trial following completion of the core study. 

STROKE

Title: Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
PI: Bruce P Hermann, PhD
Sponsor: Columbia University/NIH

This study is enrolling participants in both the surgical and medical groups of the COSS study. The purpose of the research is to evaluate whether restoring the blood flow to the brain (with EC-IC Bypass surgery) will improve mental functioning. By comparing the mental functioning of the participants in both treatment groups over the course of 2 years, it is hoped that at the end of the study, it will be known whether the EC-IC bypass operation also helps improve mental functioning. 

Title: Insulin Resistance Intervention after Stroke Trial (IRIS)
PI: Justin Sattin, MD
Sponsor: Yale University

This is a randomized, double-blinded, placebo-controlled trial of pioglitazone (Actos) for the prevention of recurrent stroke and other vascular events. The trial includes subjects who are not diabetic, but have insulin resistance as determined by an investigational blood test.

Title: Desmoteplase in Acute Ischemic Stroke Trial (DIAS-4)
PI: Matthew Jensen, MD
Sponsor: Lundbeck/Quintiles

This is a randomized, double-blinded, placebo-controlled, phase III trial of a new thrombolytic drug derived from the vampire bat, Desmodus rotundus. Participation in this trial is pending.

PARKINSON DISEASE

Title: Correlation of Functional Brain Images with Parkinson Disease Symptoms:  Comparison of FMT and FDOPA
PI: Cathy Gallagher, MD
Sponsor: Department of Veterans Affairs Office of Career Development, UW ICTR

In Parkinson disease, a group of brain cells that make a signaling substance called dopamine die off. This study will be evaluating both Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) brain images as biomarkers for Parkinson disease. We will also be comparing tests of thinking and behavior to these brain pictures to better understand how changes in dopamine influence behavior and mood in Parkinson disease. 

CONTACT INFORMATION

For more information on the trials listed above please contact:
Inquiry number: 1-800-755-5667
E-mail: ctrials@clinicaltrials.wisc.edu

Other helpful links
Ongoing Studies at the University of WI
Office of Clinical Trials Research Areas
Clinical Trials in the U.S.
CenterWatch listing service - Neurology
NIH Clinical Center