Current Clinical Studies

Enrolling Neurology Trials

Epilepsy:

- An Open-Label, Non-Interventional Study of Rufinamide to CharacterizePalatability and Acceptability of Rufinamide Oral Suspension in Subjects Aged 1 to 12 Years with Lennox-Gastaut Syndrome (E2080-A001-502): A brief study of the acceptability of the taste of Rufinamide liquid suspension in children ages 1-12 with Lennox-Gastaut Syndrome.

  Contact: Study Coordinator – Dawn Baker at dawn.baker1@uky.edu

- A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. (GWEP1424): This is a safety and efficacy study of cannabidiol in children and young adults who have been diagnosed with Dravet syndrome.

  Contact: Study Coordinator – Dawn Baker at dawn.baker1@uky.edu

- 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 (GWEP 1415): This is a long-term follow-up study of patients with Dravet or Lennox-Gastaut syndromes who completed the 1423 study.

  Contact: Study Coordinator – Dawn Baker at dawn.baker1@uky.edu

- A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAGE-547 injection in the treatment of subjects with super-refractory status epilepticus (547-SSE-301): This is a study for patients with continued status epilepticus who have failed 3rd line agents.

  Contact: Study Coordinator – Patricia Arnold at pat.arnold@uky.edu

- RNS® system Post-Approval Study in Epilepsy (NP10012): This is a post-Marketing study of the RNS® (Responsive Neurostimulation) system in patients with drug resistant or medically refractory epilepsy.

  Contact: Study Coordinator – Patricia Arnold at pat.arnold@uky.edu

Stroke:

- 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): This study compares rivaroxaban and aspirin in patients with an embolic stroke of unknown cause.

  Contact: Study Coordinator – Patricia Arnold at pat.arnold@uky.edu

- A Phase IIIb, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients with Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Defecits (PRISMS): This study provides Alteplase or placebo and Aspirin or placebo within 3 hours of last known well-state to patients with mild stroke with rapidly improving symptoms and minor neurologic deficits.

  Contact: Study Coordinator – Patricia Arnold at 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 study administers Qpi-1007 directly into the eye for patients with non-arteritic anterior ischemic optic neuropathy.

  Contact: Study Coordinator – Dawn Baker at dawn.baker1@uky.edu

Parkinson’s:

- 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 uses Tozadenant or placebo pills twice a day in PD patients whose PD medications “wear off” (quit working) prior to their next scheduled dose.

  Contact: Study Coordinator – Renee Wagner at renee.wagner@uky.edu

- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (“OFF” Episodes) (CTH-300): Study medication or placebo is used as needed and applied under the tongue to treat motor fluctuations (“OFF” episodes) between regular scheduled doses of PD medications. 

  Contact: Study Coordinator – Renee Wagner at renee.wagner@uky.edu

- 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 medications for new patients or those who completed CTH-300 study. 

  Contact: Study Coordinator – Renee Wagner at renee.wagner@uky.edu

- DUOdopa/Duopa in Patients with Advanced Parkinson's Disease (PD) – a GLobal Observational Study Evaluating Long-Term Effectiveness (DUOGLOBE): This is a post marketing study of carbidopa-levodopa enteral suspension (Duopa) use in patients with Advanced Parkinson’s Disease.

  Contact: Study Coordinator – Renee Wagner at renee.wagner@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 – Janet Greene at janet.greene@uky.edu

Neurology Trials Closed to Enrollment (Enrolled Patients)

Epilepsy:

- A Multicenter, Open-Label, Long-Term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects with Epilepsy with Partial-Onset Seizures (EP0034):  This is a long term extension study of the antiepileptic drug Lacosamide for patients that completed previous SP0969 study.

- An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Partial Onset Seizures. (UCB NO1379): This is a long term, open-label study of the antiepileptic drug, Brivaracetam, in patients 16 or older with partial onset seizures.

Parkinson’s:

- 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.

 

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