Research Program Overview

The University of Louisville Department of Neurology has a very innovative and active clinical research program. We are committed to bringing the highest quality clinical research initiatives to the University of Louisville, the City of Louisville and the Commonwealth of Kentucky. Our faculty and staff are pursuing the latest cutting edge therapies and treatments for all neurological diseases and conditions. In our partnership with the University of Louisville Hospital, we are advancing our knowledge in the areas of acute stroke treatments, potential therapies to treat Multiple Sclerosis and acute seizure and headache treatments. The Division of Pediatric Neurology is also very active in research and we are working to ensure that the treatments used in children are as safe and effective as they are for adults. We work closely with Kosair Children’s Hospital and are steadfast in our dedication to providing the best scientific information and evidence on the safety and effectiveness of treatments for neurological disorders in children.

Facilities and Equipment

The research clinic at Kentucky Neuroscience Research is completely outfitted with the equipment and resources to accomplish research objectives in line with ICH/GCP guidelines. Our facility can accommodate all types of research requirements from Phase I through Phase IV, in both pediatric and adult neurology. We are committed to collecting the highest quality data and our research equipment is calibrated and monitored regularly. We have the following equipment at our site for research purposes:

Laboratory Equipment
-70°C specimen freezer
-20°C specimen freezer (2*)
-2°C to 8°C specimen refrigerator (2*)
-2°C to 8°C drug storage refrigerator
-18°C to 4°C portable drug storage refrigerator/freezer**
-9°C to 40°C Centrifuge (24 and 16** sample capacity)
Ambient centrifuge (2)
Ice maker/ice baths

Clinical Equipment
Electrocardiography (ECG) (2*)
Electroencephalography (EEG)
Ambulatory EEG
Electromyography (EMG) (2)
Scales (adult and pediatric)
Stadiometer
Measuring table
Sphygmomanometer (including pediatric cuffs)
Mercury (1)
Aneroid (3)
Dynamap (1)
Automatic (3)
Phlebotomy laboratory (complete with CLIA waiver)

Office Equipment and Facilities
Savin scanner/fax/copier
High speed DSL access
TV/DVD/Cable for all day subject visits
Dedicated exam rooms (5)
Monitor work area (can accommodate 3 monitors concurrently)
Research drug storage room (temperature controlled-limited access)
Double lock drug cabinet
* There is one piece of equipment at KNR and ULH.
** This piece of equipment is at ULH.

The University of Louisville Hospital is a state of the art facility with all of the necessary equipment essential to providing the highest quality inpatient care. MRI, MRA, SPECT, PET, CT, complete laboratory and pharmacy, a neurodiagnostic lab, epilepsy monitoring unit and sleep labs, are all available for research use.

Kosair Children’s Hospital is the only free-standing, full-service pediatric care facility dedicated exclusively to caring for children. The Kosair Charities Pediatric Clinical Research Unit (KCPCRU) is also one of 13 sites in the Pediatric Pharmacology Research Unit (PPRU) network, a cooperative network of clinical pediatric pharmacology research sites in the United States funded by the National Institute of Child Health and Human Development (NICHD).

List of Investigator Primary Research Interests
Irene Litvan, MD Movement Disorders
Michael Sowell, MD Pediatric Neurology and Adult Headache
Pradeep Modur, MD Epilepsy
Kerri Remmel, MD, Ph.D. Stroke
Vinay Puri, MD Pediatric Neurology
Stephen Kirzinger, MD Multiple Sclerosis and Cognitive Impairment

Staff

Ronald S. Smith
Research Manager
Tel: (502) 589-6990 x230
Fax: (502) 589-7310
Email: rssmit08@gwise.louisville.edu

Patricia Wolf
Regulatory Compliance Manager
Tel: (502) 589-6990 x248
Fax: (502) 589-7310
Email: pawolf01@gwise.louisville.edu

Kathy Wohlschlegel
Regulatory Documents Coordinator
Tel: (502) 589-6990 x240
Fax: (502) 589-7310
Email: klwohl01@gwise.louisville.edu

Angela Siegwald, RN, CCRC, MSCN
Clinical Research Coordinator
Tel: (502) 589-6990 x247
Fax: (502) 589-7310
Email: amburk01@gwise.louisville.edu

Debra Brodfuehrer, CCRC
Clinical Research Coordinator
Tel: (502) 589-6990 x254
Fax: (502) 589-7310
Email: dlbrod01@gwise.louisville.edu

Jolena Richerson, CCRC, CST
Clinical Research Coordinator
Tel: (502) 589-6990 x276
Fax: (502) 589-7310
Email: jdrich10@gwise.louisville.edu

Jennifer Glenn, ARNP
Pediatric Clinical Research Coordinator
Tel: (502) 589-6990 x246
Fax: (502) 589-7310
Email: jkglen02@gwise.louisville.edu

Ann Jerde, RN
Clinical Research Coordinator
Tel: (502) 589-6990 x245
Fax: (502) 589-7310
Email: aljerd01@gwise.louisville.edu

Jeanette Billharz
Administrative Assistant
Tel: (502) 589-6990 x253
Fax: (502) 589-7310
Email: jfbill01@gwise.louisville.edu

 

Current Studies

 

Acute Stroke

A prospective, randomised, double-blind, placebo-controlled, single bolus, multinational, multi-centre, parallel group, dose ranging study of desmoteplase (INN) in the indication of acute stroke (DIAS-2)

The ALIAS Trial, -- a phase III randomized, controlled, multicenter clinical trial of albumin therapy for neuroprotection in acute ischemic stroke

Secondary Stroke Prevention

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients with a Stroke and /or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale (CLOSURE I)

Adherence eValuation After Ischemic Stroke Longitudinal – AVAIL Stroke Registry

Epilepsy/Seizure

A Multicenter, Double-Blind, Randomized, Parallel-Group Evaluation of LAMICTAL XR Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures

A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures

Post Herpetic Neuralgia

A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 For TheTreatment of Postherpetic Neuralgia

Multiple Sclerosis

#008-05-AVX--Impact of Neutralizing AntibodieS on Interferon Responsive Genes HighlighTs Biomarker Response - INSIGHT Study

A Randomized, Controlled, Open-label Parallel Study to Evaluate the Effect of Scheduled Neutralizing Antibody Testing on Treatment Patterns versus Usual Care in High-Dose Interferon Treated Patients

 

Future Studies (planned to open in the next 3-6 months)

 

Acute Stroke

A Phase IIa Randomized, Double-Blind, Parallel-Groups, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0724 Intravenous Infusion on the Amelioration of Neurological Damage and Recovery from Middle Cerebral Artery Ischemic Stroke

Secondary Stroke Prevention

The Insulin Resistance Intervention after Stroke Trial (IRIS): A Randomized, Placebo-Controlled Trial of Pioglitazone, Compared with Placebo, for Prevention of Stroke and Myocardial Infarction after Ischemic Stroke and Transient Ischemic Attack

Epilepsy/Seizure

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Subjects with Partial Onset Seizures Followed by an Open-Label Extension Study

Multiple Sclerosis

A 24-month D-B, R, MC, P-C, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 Fingolimod Orally vs Placebo in Pts w Relapsing-remitting Multiple Sclerosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study of Subcutaneous Tovaxin in Subjects with Clinically Isolated Syndrome or Relapsing-Remitting Multiple Sclerosis

Study to Assess Comparative Tolerability Measures of New Formulation of Rebif in a Population of "Interferon Naive" Relapsing Remitting Multiple Sclerosis Patients

A double-blind, placebo-controlled, randomized, parallel-group Phase II study in patients with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of 500 mg once daily and 500 mg CDP323 twice daily over 24 weeks with a rater-blinded MRI follow-up over 12 weeks

Alzheimer’s Disease

A Phase II, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-ranging Study Assessing the Efficacy and Safety of AC-3993 Tablets Twice Daily in Adults with Mild to Moderate Alzheimer's Disease

Parkinson’s Disease

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson’s Disease Patients with Motor Fluctuations

Diabetic Neuropathy

Phase II Study of QR-333 For the Treatment of Symptomatic Diabetic Peripheral Neuropathy

Migraine

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Efficacy and Safety of Oral MK-0974 with Placebo for the Acute Treatment of MigraineWith or Without Aura

Long-Term Intermittent Treatment of Acute Migraine with MK-0974 300mg

 

Contact information

Please contact Ronald S. Smith, Research Manager, with all questions or correspondence related to any aspect of conducting a clinical research trial with the University of Louisville Department of Neurology.

Directions to Kentucky Neuroscience Research

Address: Kentucky Neuroscience Research
601 South Floyd Street
Suite 503
Louisville, KY 40202
Telephone: (502) 589-6990
Fax: (502) 589-7310

From I-65 northbound (from Louisville International Airport (SDF)

Take I-65N to the Broadway exit (136A) and merge in to the middle lane, going straight through the light at Broadway Street (Route 150). At the next light, turn right onto Gray Street. Go one block to Floyd Street (flashing red-four way stop).
Go straight through the intersection to the parking garage entrance. Parking available on the third floor for visitors and patients. (If you are a patient you can valet park, by turning left at the flashing red-four way stop and taking a right in front of the Children's Hospital Foundation Building.)

From I-64 Westbound

Take I-64W to the River Road exit (58) to 3rd Street/Downtown. Go straight through the light and stay on 3rd Street until you get to the intersection with Chestnut Street (about six blocks). Take a left onto Chestnut Street and go to Floyd Street (about four blocks). Take a right onto Floyd Street, if you are a patient you can valet park at the front of the Children's Hospital Foundation Building or continue to the flashing red-four way stop and take a left to the parking garage entrance. Parking is available on the third floor for visitors and patients.

From Parking Garage

Take the pedway on the third floor to NortonHospital/Kosair/Children's Hospital Foundation Building. The pedway will fork, do not crossover Floyd St., continue straight and you will be on the second floor of the Children's Hospital Foundation Building, 601 South Floyd Street, take the elevator to the fifth floor, we are located at Suite 503.