Clinical Neurology Research

Our passion is to bring large scale clinical research to our local community in order to facilitate access to trials that are typically conducted at prominent universities and research centers in larger metropolitan areas.

Full Research Team at Vero Beach Neurology

Personalized care, professional expertise

Vero Beach Neurology & Research Institute was established in 2016 and is owned and operated by Dr. Stuart J. Shafer. With his team of Principal Investigators, Sub-Investigators and Study Coordinator’s they have been conducting Clinical Trials in many therapeutic areas in Indian River County. These trials are national as well as global.

Current Research Studies

Each member of the research team has brought their own individual research knowledge and experience to the company. All are well versed in all aspects of conducting clinical research from the patient level to the Sponsor level. Below you can find all available clinical trials.

The Exchange Study/Novartis

Exploring the safety and tolerability of conversion from oral or injectable disease modifying therapies to dose-titrated Oral Siponimod in patients with advancing forms of relapsing multiple sclerosis: A 6 month open label, multi-center Phase IIIb study.

Protocol Number: CBAF312AUS02

Key Inclusion

  • 18-65 years of age
  • Patients with advancing RMS or secondary progressive as defined by the principal investigator
  • Having been continuously treated with beta-interferons, glatiramer acetate, fingolimod, fumarates (dimethyl fumarate, diroximel fumarate), or teriflunomide for at least 3 months at the time of consent OR having had last natalizumab dose at least 4 weeks before screening OR last ocrelizumab dose 14 weeks prior to screening.

Key Exclusion

  • History of malignancy or any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • If patients treated with teriflunomide cannot and will not undergo accelerated elimination process
  • HR < 55 at screening, certain ECG findings, treatment with beta-blockers

O’HAND PPMS Study/Roche

A Phase IIIb multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ocrelizumab in adults with primary progressive Multiple Sclerosis.

Protocol Number: WA40404

Key Inclusion

  • Diagnosis of PPMS in accordance with the McDonald criteria
  • Age 18-65 years at the time of signing the informed consent

 

Key Exclusion

  • History of relapsing-remitting or secondary progressive MS at screening
  • Previous treatment with B-cell targeting therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, ofatumumab)

Restore/NOH Lundbeck

Symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, Pure Autonomic Failure), or Non-Diabetic Autonomic Neuropathy, or Dopamine Beta Hydroxylase deficiency.

Protocol NOH402

Key Inclusion

  • Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA, or PAF)
  • A documented drop of at least 20 millimeters of mercury in SBP within 3 min standing either in history or at screening

Key Exclusion

  • Diagnosis of hypertension that requires treatment with medications
  • History of MI or stroke within 2 years
  • Hx of cancer within the past 2 years other than successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ

Enlighten Study/Bristol Myers Squibb

A multicenter, longitudinal, open-label, single-arm study describing cognitive processing speed changes in relapsing multiple sclerosis subjects treated with ozanimod (RPC-1063)

 

Key Inclusion

  • Male or female 18-65 years of age (inclusive) at the time of signing of the informed consent.
  • Subject has < 5 years since time of RMS diagnosis.
  • Subject has been treated with < 1 approved RMS DMT at time of study enrollment.

 

Key Exclusion

  • Subject has a history of developmental disorder (eg, attention-deficit/hyperactivity disorder [ADHD], learning disorder)
  • Subject has received previous treatment with natalizumab, fingolimod, Siponimod or other S1P receptor modulators.

FENtrepid Study/Roche

A phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of fenebrutinib compared with ocrelizumab in adult patients with primary progressive multiple sclerosis.

 

Protocol Number: GN41791

 

Key Inclusion

  • 18-65 years inclusive at time of signing Informed Consent Form
  • A diagnosis of primary progressive multiple sclerosis (PPMS) in accordance to the revised 2017 McDonald Criteria.

Parkinson’s disease/Addex Pharma S.A.

ADX48621-301 Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients with Parkinson’s Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications.

Patients that participate in this trial will qualify for an additional 1-year extension trial.

Key Inclusion

  • Male or female patients between 30 and 85 years of age, inclusive.
  • Parkinson’s disease, per UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria
  • Ambulatory or ambulatory-aided (e.g., walker or cane) ability while ON, such that the patient can complete study assessments.

 

Key Exclusion

  • History of neurosurgical intervention related to PD (e.g., deep brain stimulation)

Verismo Study/Roche

An observational study of ocrelizumab treated patients with multiple sclerosis to determine the incidence and mortality rates of breast cancer and all malignancies.

 

Key Inclusion

  • Have a diagnosis of MS
  • Newly treated with ocrelizumab (within 30 days before baseline visit [study entry]) according to the local label irrespective of the reason for starting ocrelizumab (ocrelizumab cohort)

OR

Newly treated with one of the following 6 approved MS DMTs; alemtuzumab, cladribine, dimethyl fumarate, fingolimod, natalizumab, or teriflunomide (within 30 days before baseline visit according to the local label irrespective of the reason for starting a new MS DMT (internal comparator cohort)

 

Key Exclusion

  • Patients who have any prior exposure to rituximab or to any anti-CD20 therapy for MS.
  • Active participation in interventional clinical trials for MS.

ICARE/Biogen

International Collaboration for Real-World Evidence in Alzheimer’s Disease (ICARE AD) A Prospective Real-World Observational Study of Aducanumab-avwa in Patients with Alzheimer’s Disease in the US.

 

Key Inclusion

  • Patient is at least 18 years of age at the time of informed consent. 
  • Patient has a diagnosis of AD and is prescribed aducanumab-avwa by their treating physician.
  • Patient is willing and able to complete patient reported outcomes (PRO) with minimal assistance and patient’s informant/care partner is willing and able to assist in the completion of PROs about patient’s health and treatment and the burden of caregiving.

Key Exclusion

  • Patient concurrently participates in any interventional clinical study. Participation in other non-interventional studies is permitted.

Our Research Team

VBNRI is involved in national and international clinical research trials that study not only Multiple Sclerosis, but also Parkinson’s, Stroke, Migraine, and Epilepsy. In partnership with Geodyssey Research, both VBNRI and MSCVB are actively involved in ongoing research and recruitment of patients into clinical trials. Meet the team that makes all this a success.

Principal Investigator

S. James Shafer, M.D.

Dr. S. James Shafer, a local resident since 1977, has practiced Adult Neurology in Vero Beach and the surrounding area since 1997. From 1997 to 2016 Dr. Shafer practiced in a multi-specialty group and in 2016 ventured in solo practice and formed Vero Beach Neurology and Research Institute. He is the founder and Medical Director of The Multiple Sclerosis Center of Vero Beach that was formed in 2001 and has cared for thousands of MS patients world-wide. While he treats all Neurological Disorders, he is a Nationally recognized MS specialist. He, additionally, has expertise in Cerebrovascular Disease and Stroke being the founding and current Medical Director of the Indian River Medical Center Stroke Program.

Sub-investigator and Examining Investigator

Stacy Smith, PA-C

Stacy attended Southern Adventist College in Collegedale, Tennessee graduating with her Associate of Science in Biology. She then attended Union College in Lincoln, Nebraska, earning her Bachelor of Science as a Physician Assistant. Stacy has been Board Certified since 2001 and has successfully completed renewal of her board maintenance. Additionally, she has been designated by demonstration of competency and clinical hours as a Multiple Sclerosis Certified Specialist.

Byron Wiley, ​Neurodiagnostics Technologist at Vero Beach Neurology & Research Institute

Examining Investigator

Bryon Wiley

Bryon is originally from the foothills of north Georgia. He has been in the field of neurology since 2009 and he has been focused on Electroneurodiagnostics since 2010. He is a registered nerve conduction study technologist through the American Association of Electrodiagnostic Technologists. He is also a certified medical assistant through the American Association of Medical Assistants. He is an active member of both associations as well as an active member of ASET – The Neurodiagnostic Society, American Association of Neuromuscular and Electrodiagnostic Medicine, and The American Clinical Neurophysiology Society. He also has significant experience in performing other Neurodiagnostic modalities including electroencephalography and evoked potentials. His background includes motorsports, computer programming and metalworking. His hobbies include going to the beach, swimming, and as he puts it, “always learning something new.

Director, Clinical Operations

Clellia Bergamino, BS

Clellia Bergamino is the Owner of Geodyssey Research, LLC. Clellia has a Bachelor of Science degree from the University of Central Florida and has worked in the medical field since 1988. Clellia began working as a Clinical Research Coordinator in 1994.


Primary responsibilities include oversite of all clinical trials within the company. Additional responsibilities include contract and budget negotiations, staff management and determining the feasibility of incoming clinical trials. In addition, she oversees the ongoing financial aspects of each clinical trial

Certified Clinical Research Coordinator

Elizabeth McFeaters, C.C.R.C

Elizabeth has working in clinical research since 2003. Her experience in research includes clinical trials working in HIV/AIDS, Cardiology, Rheumatology and Neurology. She is the senior coordinator at VBNRI, and performs all aspects of running clinical trials.

Interested in clinic trials?

Our passion is to bring large scale clinical research to our local community in order to facilitate access to trials that are typically conducted at prominent universities and research centers in larger metropolitan areas.