Current Clinical Studies

Enrolling Neurology Trials

Alzheimers:

ALS: 

Evaluation of the Safety, Tolerability, Efficacy, and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis (ALS): In this Phase II study, we are looking at two drugs that have previously been tested in individuals with ALS and showed some promise individually. The goal of this study is to see whether the combined effect of both drugs can slow down the progression of ALS. It is administered orally two times a day for 6 months.

Contact:  Study Coordinator – Meha Joshi at majo235@uky.edu (mail to: majo235@uky.edu)

A Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of H.P. Acthar Gel in the Treatment of Subjects with Amyotrophic Lateral Sclerosis: In this Phase II study, we are asking individuals with ALS to administer a corticosteroid subcutaneously (injection under the skin) daily for nine months. This is another study where the goal is to see whether this investigational drug can help slow down ALS progression.

Contact:  Study Coordinator – Meha Joshi at majo235@uky.edu (mail to: majo235@uky.edu)

Treatment of FUS-Related ALS with Betamethasone: Only open to individuals who have a known mutation in the FUS gene and ALS and/or their family members. In this inpatient study, we are looking to see whether the administration of intramuscular injections of betamethasone can help reduce oxidative stress.

Contact:  Study Coordinator – Meha Joshi at majo235@uky.edu (mail to: majo235@uky.edu)

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients with ALS: This is a phase III study in which willing ALS patients will take levosimendan or placebo as a pill. The primary goal of this study is to determine whether the study drug can improve respiratory function in patients with ALS.

Contact:  Study Coordinator – Meha Joshi at majo235@uky.edu (mail to: majo235@uky.edu)

Banking Patient Samples for the Study of Neurologic Diseases: Patients and their family members who are identified to be likely to have a specific genetic mutation may offer blood samples and/or skin biopsy samples for Dr. Kasarskis and his research team to study to learn more about the way that genetic mutation causes disease. The ultimate goal would be to determine a way to turn off the genetic mutation that causes disease; and/or to prevent the development of the disease when someone gets the genetic mutation.

Contact:  Study Coordinator – Meha Joshi at majo235@uky.edu (mail to: majo235@uky.edu)

Quantification of Sialorrhea Reduction after Unilateral Parotid Electron Beam Radiotherapy in Debilitating Neurological Disorders: Dr. Kasarskis and his research team are evaluating the effectiveness of Electron Beam Radiation in decreasing saliva production to improve the troublesome symptom of sialorrhea, or excessive saliva, in patients with ALS and other debilitating neurological disorders.

Contact:  Study Coordinators – Meha Joshi at majo235@uky.edu (mail to: majo235@uky.edu) or Meghann Bruno at meghann.bruno@uky.edu (mail to: meghann.bruno@uky.edu)

Survey of Residential History in ALS Patients Residing in Kentucky, Ohio, Indiana, West Virginia, and Tennessee: In this survey research study, we are looking for environmental factors that are associated with an increased risk for developing ALS. Willing participants are asked to complete a survey that includes their lifelong residential and occupational history (every place they have lived, and their occupation while they lived there.) This study is open to all ALS patients.

Contact:  Study Coordinator – Meha Joshi at majo235@uky.edu (mail to: majo235@uky.edu)

AWARE Quality of Life Study: Dr. Debra Suiter, PhD, Speech Language Pathologist at UK ALS Center, is conducting a clinical observational study to examine the quality of life of patients with swallowing problems related to ALS and their caregivers.

Contact:  Study Coordinators – Meha Joshi at majo235@uky.edu (mail to: majo235@uky.edu) or Meghann Bruno at meghann.bruno@uky.edu (mail to: meghann.bruno@uky.edu)

Diabetic Peripheral Neuropathy:

A Causative Role for Amylin in Diabetic Peripheral Neuropathy - Observational, Single Group – Patients with Type 2 Diabetes who show signs of Peripheral Neuropathy through a Nerve Conduction Velocity (NCV) test 1) Have a skin graph from their forearm and a blood sample collected and 2) undergo a series of sensation tests in the upper extremities – as to identify a potential correlation between the amount of amylin present in the blood and skin of the forearm and the extent of their Peripheral Neuropathy.

Contact: Study Coordinator - Nathan Moliterno at nathanterno@uky.edu (mail to: nathanterno@uky.edu) 

Epilepsy:

A prospective multi-center study comparing the performance of the Dysphagia Detection System (DDS) in detecting impaired swallowing safety and efficiency as compared to the clinical reference method - videofluorosopic swallowing study (VFSS) PORSCHE: The primary objective is to validate the DDS against the VFSS for detecting swallow safety problems using thin barium.

Contact:  Study Coordinators- Dawn Baker at dawn.baker1@uky.edu or Morgan Yazell at morgan.yazell@uky.edu

Efficacy and Safety of Eslicarbazepine Acetate as First Add-on to Levetiracetam or Lamotrigine Monotherapy or as Later Adjunctive Treatment for Subjects with Uncontrolled Partial-onset Seizures: A Multicenter, Open-label, Non-randomized Trial: This study is to evaluate the effectiveness of ESL administered once daily as the first add on therapy to Levetiracetam or Lamotrigine in people with Partial Onset seizures.

Contact:  Study Coordinators- Dawn Baker at dawn.baker1@uky.edu or Michael Nsoesie at michael.nsoesie@uky.edu

An Open-Label, Multicenter Study with an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension when Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to less than 12 years) with Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic-Clonic Seizures - A one-year study to determine the safety and efficacy of perampanel in children 4-11 years of age. 

Contact: Study Coordinator-Pat Arnold at pat.arnold@uky.edu (mail to: pat.arnold@uky.edu)

An Open-Label Study With an Extension Phase to Evaluate the Pharmacokinetics of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Subjects From 1 Month to Less Than 24 Months (<2 years) of Age With Epilepsy

Contact: Study Coordinator-Pat Arnold at pat.arnold@uky.edu (mail to: pat.arnold@uky.edu)

Parkinson's:

An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (“OFF” Episodes) (CTH-301): Open label study medication is used as needed and applied under the tongue to treat motor fluctuations (“OFF” episodes) between regular scheduled doses of PD medication for new patients or those who completed CTH-300 study.

Contact:  Study Coordinator – Renee Wagner at renee.wagner@uky.edu (mail to: renee.wagner@uky.edu)

An Open-Label Study in Subjects with Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment (M15-579) Open label study medication is delivered by continuous subcutaneous infusion via external pump in patients who experience motor complications inadequately controlled by oral medications.

Contact:  Study Coordinators – Renee Wagner at renee.wagner@uky.edu (mail to: renee.wagner@uky.edu) or Michael Nsoesie at michael.nsoesie@uky.edu (mail to: michael.nsoesie@uky.edu

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24-Hour and 72-Hour Subcutaneous Infusions of ABBV-951 in Subjects with Parkinson's Disease (M15-738) This is an in-patient study where patients receive a dose of study medication delivered by continuous subcutaneous infusion via external pump over either 24 or 72 hours and is for patients who experience motor complications inadequately controlled by oral medications.

Contact:  Study Coordinators – Renee Wagner at renee.wagner@uky.edu (mail to: renee.wagner@uky.edu) or Michael Nsoesie at michael.nsoesie@uky.edu (mail to: michael.nsoesie@uky.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson’s Disease (PD) (NILO-PD) The first cohort of the study is for moderate to advanced PD patients taking levodopa and the second cohort is for early untreated PD patients. 

Contact:  Study Coordinators – Renee Wagner at renee.wagner@uky.edu (mail to: renee.wagner@uky.edu) or Michael Nsoesie at michael.nsoesie@uky.edu (mail to: michael.nsoesie@uky.edu 

A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER.  (P2B001) Study combining low dose combination of pramipexole and rasagiline into an extended release product (single pill) and comparing the combination product to the individual medications. 

Contact:  Study Coordinators – Renee Wagner at renee.wagner@uky.edu (mail to: renee.wagner@uky.edu) or Michael Nsoesie at michael.nsoesie@uky.edu (mail to: michael.nsoesie@uky.edu

Continuation of a Pilot Study to Evaluate the Safety and Feasibility of Implanting Autologous Peripheral Nerve Grafts into the Substantia Nigra of Subjects with Parkinson’s Disease Undergoing Deep Brain Stimulation Surgery and Treatment (APGN)  Study implanting sural nerve graft into substantia nigra of PD patients who are undergoing DBS surgery.

Contact:  Study Coordinator - Morgan Yazell at morgan.yazell@uky.edu (mail to: morgan.yazell@uky.edu

Exploring dopamine transporter single-photon emission computed tomography quantification as a measure of disease progression in idiopathic Parkinson's disease Study using CT-SPECT in combination with DaTscan to obtain confirmation of Parkinson's disease in patients that have been diagnosed, and to test if this method could be helpful in monitoring disease progression.

Contact: Study Coordinator – Morgan Yazell at morgan.yazell@uky.edu (mail to: morgan.yazell@uky.edu)

Progressive Supranuclear Palsy (PSP):

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy (M15-562): This is a 52 week multi-center phase 2 study using an anti-human tau antibody administered via IV infusion for PSP patients who have had PSP symptoms for less than 5 years.

Contact:  Study Coordinators – Renee Wagner at renee.wagner@uky.edu (mail to: renee.wagner@uky.edu) or Michael Nsoesie at michael.nsoesie@uky.edu (mail to: michael.nsoesie@uky.edu

Stroke:

A Phase 1B/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study To Assess The Safety, Pharmacokinetics and Pharmacodynamics of DS-1040B In Subjects With Acute Ischemic Stroke: This is a 90 day study to determine if intravenous DS-1040B is safe and effective in subjects with acute ischemic stroke who do not qualify for tPA or thrombectomy.

Contact: Study Coordinator-Pat Arnold at pat.arnold@uky.edu (mail to: pat.arnold@uky.edu)

AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke: This is a four year study to determine if apixaban vs. Aspirin is effective in patients after a cryptogenic stroke.

Contact: Study Coordinator-Pat Arnold at pat.arnold@uky.edu (mail to: pat.arnold@uky.edu)

Neuro Ophthalmology:

A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered by Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) - This is a 12 month multicenter global study using siRNA synthetic to counteract degradation of cells surrounding the optic nerve. 4 intravitreal injections administered with 4 months and 6 months of follow up.

Contact: Study Coordinators - Nathan Moliterno at nathanterno@UKY.EDU (mail to: nathanterno@uky.edu) or Michael Nsoesie at michael.nsoesie@uky.edu (mail to: michael.nsoesie@uky.edu)  

Pediatric Optic Neuritis Prospective Outcomes Study (PON1) - A 12 month study with objective to collect information about children who have optic neuritis, learn about the characteristics of these children and study what happens to their eyesight.

Contact: Study Coordinators - Nathan Moliterno at nathanterno@UKY.EDU (mail to: nathanterno@uky.edu) or Michael Nsoesie at michael.nsoesie@uky.edu (mail to: michael.nsoesie@uky.edu)

Retinal Imaging as a biomarker for Prodromal Alzheimer’s disease and Vascular Dementia - A pilot study hypothesizing Optical Coherence Tomography will detect a forme fruste of the pathology seen in Mild Cognitive Impairment and Alzheimer’s disease in cases with preclinical Alzheimer’s disease. Hypothesize that these findings will be discretely different between preclinical Alzheimer’s and vascular dementia adjusted for age, gender and disease duration. 

Contact: Study Coordinators - Nathan Moliterno at nathanterno@UKY.EDU (mail to: nathanterno@uky.edu) or Michael Nsoesie at michael.nsoesie@uky.edu (mail to: michael.nsoesie@uky.edu) 

Neurology Trials Closed to Enrollment (Enrolled Patients) 

Phase 3 Double-Blind, Placebo-Controlled, Parallel Group Study of Isradapine as a Disease Modifying Agent in Subjects with Early Parkinson Disease (Steady PD III):  This is the study of a potential disease modifying agent in patients who have been diagnosed with PD less than 3 years and who are not using any medications to treat their PD.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End-of-Dose “Wearing-Off” (TOZ-PD) – This study used Tozadenant or placebo pills twice a day in PD patients whose PD medications “wear off” (quit working) prior to their next scheduled dose.

An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes 

A Phase 2 Randomized, Double Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects with Amyotrophic Lateral Sclerosis (ALS) and Evidence of High Systemic Inflammation: A Phase II study in which NP001 or placebo was infused intravenously in ALS patients with high levels of hs-CRP (a marker of elevated baseline inflammation). It is believed that it can possibly bring down the inflammation of the nerve cells and slow the progression of ALS.

Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg (NAVIGATE ESUS).

 

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