Neurology Research

We have a proud tradition in developing novel treatments for stroke. Augusta University has a long tradition of investigator-initiated stroke clinical stroke trials, translational stroke research, and both leading and participating in NIH-sponsored cooperative trials.

Our activities have spanned the phases of clinical trial activities from a strong pre-clinical “translational” program that has developed the scientific rationale and premise for clinical trials, to phase I and II trials that have established dosing, safety and pharmacokinetics, and finally to phase III trials designed and initiated to establish efficacy.

CURRENT RESEARCH STUDIES          COMPLETED RESEARCH STUDIES

 

PISCES III : A CLINICAL RESEARCH STUDY OF STEM CELLS FOR PATIENTS WITH ONGOING DISABILITY AFTER STROKE

**Right now this phase of the trial only accepts patients that have had a stroke in the last 6-12 months.

Current Research Studies

Stroke

more information on CURRENT STROKE STUDIES

 

  • CAPTIVA - Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
  • PRECISE - Perfusion imaging to identify posterior circulation candidates for thrombectomy
  • Remote ischemic conditioning - Early phase clinical study to evaluate the response of selected blood biomarkers to remote ischemic conditioning. In addition, to evaluate the tolerability and adherence to the treatment protocol using a dose escalation design.
  • RBC deformability in acute stroke - Compared to age matched controls, In addition, RBC nitric oxide, RBC NOS3, and plasma nitrite levels are compared.
  • SATURN - A multi-center, prospective randomized, phase 3, pragmatic, open-label, and blinded end-point assessment (PROBE) clinical trial to determine the effects of continuation vs. discontinuation of statins on the risk of intracerebral hemorrhage (ICH) recurrence in patients with lobar hemorrhage.
  • ASPIRE - A randomized, double-blinded, phase 3 clinical trial designed to test the efficacy and safety of apixaban, compared with aspirin, in patients with a recent intracerebral hemorrhage (ICH) and high-risk non-valvular atrial fibrillation.

Movement and Memory

  • A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
  • PSP: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy 
  • DAYBREAK: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s Disease Dementia
  • CONGA:  This study will evaluate the neurological manifestations of COVID-19 infection within a prospective cohort of 1,000 patients in Georgia and monitor these over a five-year time period with a focus on cognition, smell and taste testing alongside molecular genetic, epigenetic, serologic, proteomic, and metabolomic studies.

National Parkinson Foundation Patient Registry

  • 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)
  • 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
  • Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment with NLY01 in Early-stage Parkinson’s Disease 
  • Rostock International Parkinson’s Disease Study - An international, multicentre, epidemiological observational study
  • A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson’s Disease Psychosis
  • A Randomized Placebo-controlled Trial of Zoledronic Acid for Prevention of Fractures in Patients with Parkinson’s Disease (Referral Center)
  • A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, 27-WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)
  • MIND: Long-Term Nicotine Treatment of Mild Cognitive Impairment 

Myasthenia Gravis

  • Alexion 306: Ravulizumab is a C5 complement inhibitor and is being studied for safety and efficacy in ACHR positive Myasthenia Gravis via intravenous (IV) infusions every 8 weeks. Open Label use (no placebo) of Ravulizumab is offered to study participants after study completion.
  • MG0003: Rozanolixizumab is an FCRN inhibitor and is being studied for safety and efficacy in ACHR or MuSK positive Myasthenia Gravis via weekly subcutaneous injections. Open Label use (no placebo) of Rozanolixizumab is offered to study participants after study completion.
  • RAISE: Zilucoplan is a C5 complement inhibitor and is being studied for safety and efficacy in ACHR positive Myasthenia Gravis via daily subcutaneous injections. Open Label use (no placebo) of Zilucoplan is offered to study participants after study completion.
  • Takeda: TAK-079 is a monoclonal antibody directed against CD38 (B cells) and is being studied to determine safety, tolerability, and efficacy in ACHR or MuSK positive Myasthenia Gravis via weekly subcutaneous injections.
  • Alexion 501: This is an observational study hoping to collect data on patients who are currently taking eculizumab and have ACHR positive Myasthenia Gravis.

Amyotrophic Lateral Sclerosis

  • Anelixis: AT-1501 is a monoclonal antibody directed against CD40LG (T cells) and is being studied for safety and tolerability in ALS via bi-weekly (every other week) intravenous infusions (IV) with no use of placebo throughout the study.
  • COMBAT: Ibudilast is a neuroprotective agent that is being studied for safety and efficacy in ALS via oral capsules taken daily.
  • Apellis: Pegcetacoplan is a C3 complement inhibitor being studied for safety and efficacy in ALS via subcutaneous infusions twice per week.
  • -Chronic Inflammatory Demyelinating Polyradiculoneuropathy -
  • CIDP01:Rozanolixizumab is an FCRN inhibitor and is being studied for safety and efficacy in CIDP via weekly subcutaneous infusions. Open Label use (no placebo) of Rozanolixizumab is offered to study participants after study completion.
  • -Lumbar Disk Herniation-
  • SKK—SI-6603: an intradiscal injection in the lower back that aims to use Condoliase to alleviate disc pressure and the compression of the nerve root causing back & leg pain.

Spasmodic Dysphonia

  • Firdapse in SD: Amifampridine is used to increase the amount of acetylcholine in muscles and is being studied to determine whether it is effective in reversing side effects from SD treatments via oral tablets taken daily for 2 weeks.

Stroke Studies

 

ARPEGGIO - A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke
CAPTIVA - Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis

Masters2 - MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

PRECISE - Perfusion imaging to identify posterior circulation candidates for thrombectomy
RBC deformability in acute stroke - Compared to age matched controls, In addition, RBC nitric oxide, RBC NOS3, and plasma nitrite levels are compared.
Remote ischemic conditioning - Early phase clinical study to evaluate the response of selected blood biomarkers to remote ischemic conditioning. In addition, to evaluate the tolerability and adherence to the treatment protocol using a dose escalation design.
LibreXIa-Stroke - A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
 

Completed Research Studies

-Essential Tremor-

Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor

PROSPECT: Prospective study for Symptomatic relief of Essential tremor with Cala Therapy (POSITIVE study)

-Parkinson’s Disease-

Levodopa Inhalation Powder: A Review in Parkinson’s Disease

Tozadenant (SYN115) in patients with Parkinson’s disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial

A Phase 3, Open-Label Study of the Safety, Efficacy, and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson’s Disease Patients with Unsatisfactory Control on Available Therapy

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)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)

A 12-Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena)

Factors Associated with Leukoaraiosis Severity in Acute Stroke Patients

Objective: Age-related cerebral white matter abnormalities, commonly termed leukoaraiosis (LA), are frequent manifestation of cerebral microvascular disease. Aging and hypertension are well linked to LA. We compared additional vascular risk factors and socioeconomic factors with LA severity in acute stroke patients. Methods: We analyzed 271 patients with acute ischemic or hemorrhagic stroke from a hospital registry. We collected clinical and socioeconomic data prospectively with a standardized questionnaire during acute stroke hospitalization. We scored LA severity on all available head computed tomography and magnetic resonance imaging (MRI) scans with the Wahlund LA scale. Mean response modeling analyzed for associations between LA severity and multiple potential predictors. Results: Among 238 patients with CT LA scores, ageing and history of hypertension emerged as independent predictors of LA severity in multivariable analysis. Among 186 patients with MRI LA scores, ageing and severe left ventricular hypertrophy emerged as independent predictors of LA severity in multivariable analysis. We did not find an independent significant association between LA severity and the other factors we tested. Conclusions: Our study confirms the association of LA severity with ageing, and with hypertension. However, other vascular and socioeconomic factors we tested were not independently associated with LA severity.

Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA

Combination antiplatelet therapy with clopidogrel and aspirin may reduce the rate of recurrent stroke during the first 3 months after a minor ischemic stroke or transient ischemic attack (TIA). A trial of combination antiplatelet therapy in a Chinese population has shown a reduction in the risk of recurrent stroke. We tested this combination in an international population.

Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke

The SHINE Randomized Clinical Trial

OBJECTIVES To determine the efficacy of intensive treatment of hyperglycemia during acute ischemic stroke.

Randomized Trial of Thymectomy in Myasthenia Gravis

Thymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone.

New CT measurements to assess decompression after hemicraniectomy: A two-center reliability study

Objectives: To test the reliability of three simplified measurements made after decompressive hemicraniectomy (DHC) for malignant hemispheric infarction on computed tomography (CT) scan. Patients and methods: We defined new simple methods to measure the thickness of the soft tissues overlying the craniectomy defect and the extent of infarction beyond the anterior and posterior craniectomy edges on post- DHC CT. Multiple raters independently made the three new CT measurements in 49 patients from two institutions. The Intraclass Correlation Coefficient (ICC) compared the raters for interrater agreements (reliability). Results: Between two raters at Augusta University Medical Center, each measuring 21 CT scans, the ICC coefficient point estimates were good to excellent (0.83 – 0.92). Among four raters at University of Virginia Medical Center, with three raters measuring each of 28 CT scans, the ICC coefficient point estimates were good to excellent (0.87 – 0.95). Conclusions: The proposed simple methods to obtain three additional CT measurements after DHC in malignant hemispheric infarction have good to excellent reliability in two independent patient samples. The clinical usefulness of these measurements should be investigated.

Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2

Multipotent adult progenitor cells are a bone marrow-derived, allogeneic, cell therapy product that modulates the immune system, and represents a promising therapy for acute stroke. We aimed to identify the highest, well-tolerated, and safest single dose of multipotent adult progenitor cells, and if they were efficacious as a treatment for stroke recovery.


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