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Clinical Trials

CLEAR III
A Phase III randomized clinical trial (RCT) using recombinant tissue plasminogen activator (rtPA), to treat subjects with intracerebral hemorrhage (ICH), intraventricular hemorrhage (IVH), and hydrocephalus.

Principal Investigators: Martin Gizzi, MD, PhD; Thomas Steineke, MD, PhD; Jawad Kirmani, MD
Study Coordinator: Charles Porbeni, MD, MSc


MISTIE
Minimally Invasive Surgery plus rt-PA for ICH Evacuation
The Study propose to produce data regarding the capability of minimally invasive surgery (MIS) with recombinant tissue plasminogen activator (rt-PA) to remove blood clot from ICH patients.

Principal Investigators: Martin Gizzi, MD, PhD; Thomas Steineke, MD, PhD; Jawad Kirmani, MD
Study Coordinator: Charles Porbeni, MD, MSc


NAION
Nonarteritic Anterior Ischemic Optic Neuropathy

Principal Investigators: Martin Gizzi, MD, PhD; Michael Rosenberg, MD
Study Coordinator: Charles Porbeni, MD, MSc


2CARE
Coenzyme Q10 in Huntington's Disease (HD)

Principal Investigator: Philip Hanna, MD
Study Coordinator: Charles Porbeni, MD, MSc


CREST-E
Creatine Safety, Tolerability, & Efficacy in Huntington’s Disease (CREST-E)

Principal Investigator: Philip Hanna, MD
Study Coordinator: Charles Porbeni, MD, MSc


Physiological Brain Atlas Development

Principal Investigator: Peter Zahos, MD
Study Coordinator: Charles Porbeni, MD, MSc


SP902
A historical-controlled, multi-center, double-blind, randomized trial to assess the efficacy and safety of conversion to Lacosamide 400mg/day monotherapy in subjects with partial-onset seizures.

Principal Investigator: Wei Ma, MD


SP904
A multi-center, open-label extension trial to assess the long-term Use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures.

Principal Investigator: Wei Ma, MD


Novo-cure EF14
A prospective, multi-center trial of NovoTTF-100A compared to best standard of care in patients with Progressive or Recurrent GBM.

Principal Investigator: Joseph Landolfi, DO
Study Coordinator: Charles Porbeni, MD, MSc


Florida Center for Brain Tumor Research
Collaboration with the Florida Cancer Data System to make available for research a brain tumor registry that is an automated, electronic, and centralized database of individuals with brain tumors.

Principal Investigator: Peter Zahos, MD


ATACH II
Antihypertensive Treatment of Acute Cerebral Hemorrhage: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage

Principal Investigators: Jawad Kirmani, MD; Martin Gizzi, MD, PhD; Panezai Spozhmy, MD
Study Coordinator: Charles Porbeni, MD, MSc
Awaiting IRB approval


AP 12009-G005
Efficacy and safety of AP 12009 in adult patients with Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) as compared to standard treatment with Temozolomide or BCNU: a randomized, actively controlled, open label clinical Phase III Study. (SAPPHIRE)

Awaiting IRB approval


Droxidopa-302
Phase III multi-center, double-blind, randomized, placebo-controlled, parallel-group withdrawal-design study to assess the clinical effect of Droxidopa in subjects with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotension.

Closed to enrollment


Droxidopa-303
A multi-center, open-label study, with a two week randomized, placebo-controlled, withdrawal period, to assess the long-term safety and clinical benefit of Droxidopa in subjects with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotension.

Closed to enrollment


Novavision

Testing of a functional outcome measure for those with Visual Field Defects.


Sentis
A single blind study to evaluate the efficacy of Neuroflo device (catheter) in the acute management of ischemic stroke. Patients must be 18 years and above and should have presented to the ER within 10 hours of stroke onset.

Closed to enrollment


PFIZER A0081047-1078
A double-blind, randomized, multi-center efficacy and safety study of Pregabalin (Lyrica) as monotherapy in patients with partial seizures.

Closed to enrollment


PFIZER A0081160–1078
An open-label multi-center extension study to determine long term safety and efficacy of Pregabalin (Lyrica) as monotherapy in patients with partial seizures.

Closed to enrollment


AP 12009-G005
Efficacy and safety of AP 12009 in adult patients with Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) as compared to standard treatment with Temozolomide or BCNU: a randomized, actively controlled, open label clinical Phase III Study. (SAPPHIRE)

Awaiting IRB approval


Novo-cure EF11
An open label study to compare the efficacy of Novo-cure Device versus the best standard of care in the treatment of recurrent Glioblastoma multiforme. The device involves the use of low intensity, intermediate frequency electric fields to stunt the growth of tumor cells.

Principal Investigator: Joseph Landolfi, DO
Closed to enrollment


MRZ 60201-0408
A double blind study to investigate the efficacy and safety of different doses of a muscle relaxant in the treatment of cervical dystonia.

Principal Investigator: Philip Hanna, MD
Closed to enrollment


Xenoport (XP055)
Open-label study to evaluate the safety and efficacy of a medication used to treat Restless Leg Syndrome.

Principal Investigator: Arthur Walters, MD
Closed to enrollment


GSK 196
A long-term, open-label continuation study of once daily administration of Ropinirole CR tablets to patients with Parkinson's Disease who completed the previous Ropinirole CR studies – 167 & 164.

Principal Investigator: Philip Hanna, MD
Closed to enrollment


For more information on any Clinical Trial listed above, any interested party can call 732-321-7000 x68897.