Our physicians are not only providing clinical solutions for neurological disorder causes of today, we are committed to finding the cures of tomorrow. At PBNI, we are at the forefront of research and development for innovative techniques and technologies, and the development of medications. We also partner with global organizations, pharmaceutical companies and educational institutions to solve healthcare challenges that result in high mortality rates and/or substantially reduced quality of life.

For more information regarding our clinical research program, visit our clinical research partners at icareresearch.com

St Mary’s Medical Center & The Palm Beach Neurosciences Institute
Neurointerventional Program & Comprehensive Stroke Program

St. Mary’s Medical Center

1. Dabigatran Etexilate for Secondary Stroke Prevention in Patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS) (PI Dr. Malek, Sub I Dr. Acevedo)
Web: https://clinicaltrials.gov/ct2/show/NCT02239120

IMPORTANT
Respect Esus team currently anticipate completing enrollment in December 2017, and all patients will receive a minimum of 6 months of treatment with study medication after enrollment.
We anticipate to enroll 10 patients in total for this trial. Currently, 6 patients are enrolled and not screen failures were reported.

• Randomized 7
• Screened 1
• Pre-Screen – To consent in PBNI 1
• Total Pt Excluded – Not meet inclusion criteria 237
• Loop Recorder 7 Enrolled for Biomarker sub-study 7
• Enrolled for MRI sub study 7
• Enrolled for Assay Validation Sub Study 6
• Screen Failures 0

Unblinded Pt 1127701 – Afib found by loop recorder
Sponsor notified – Case reviewed by safety team

2. Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) ( PI. Dr. Malek)
Web: https://clinicaltrials.gov/ct2/show/NCT02478177

Requested and completed a release for GWTG codes – Aramis tab for retrospective patients from Nov 2016 – June 2017 –All Consents, Medical Releases, Patient Contact Forms, GWTG screenshots, Discharge Medications, and Baseline Quality of Life was faxed to: (919) 613-9536. No Forms Due for our site.

• Registered GWTG Total 17
• Pre- Screen 31
• AE/SAE 0
• Protocol Deviations 0

3.Trevo Retriever Registry Post Market Surveillance
Pending for closure – New investigator queries was updated and closed. Update screen log sent to the sponsor.
Web: https://clinicaltrials.gov/ct2/show/NCT02040259

• Consented 75
• Enrolled 70
• SAE reported 13
• SAE related to Intervention 0
• UB-04 75
• DICOM MRI/MRA Source I 56

4. Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART) -(SMMC) (PI. Dr Malek)
Web: https://clinicaltrials.gov/ct2/show/NCT02729740

• Enrolled 2
• CT, MRI completed 2
• SAE reported 1

5. LVO – FAU (Retrospective Study)
Required study documents, Tenet required Agreements have been executed. Retrospective study has been activated by CARE and St. Mary’s Medical Center effective September 13, 2017.

• IRB approved by Metro West IRB effective September 13, 2017
• Data review and reported from Stroke Quality Coordinator – Endovascular Rescue by discharge dates 2015 – September 2017.

6. ISTOR – St. Mary’s stroke Registry (Retrospective and prospective observational study) ( Dr Malek, Dr Acevedo)
Study documents have been executed, and the study has been built in Tenet required system (Clinical Conductor). ISTOR trial has been activated by CARE and St. Mary’s Medical Center effective October 19, 2017. SMMC may now begin screening patients for enrollment under this protocol.

• IRB# 2017-090 Approved by Metro West IRB – Sept 27, 2017
• Neuro scales (NIHSS, mRs, QOL, hunt hess scale, Glasgow coma scale, associated with this study to be stamped with the IRB approval

Comprehensive Memory Disorders Center
St Mary’s Medical Center

7. Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study (Dr. Dalvi) “Memory disorder center and PBNI”
Web: https://clinicaltrials.gov/ct2/show/NCT02420756

• Patients Enrolled 8
• Patients Completed Post Pet Scan Evaluation 4
• Patients Pre-screened for next clinic 2
• Pre-Screen total 9
• AE – SAE 0
• Screen Failures 0

Comprehensive Movement Disorders Center
The Palm Beach Neuroscience Institute

In Process (Tenet Under review):

8. CAVION Trial – A Phase 2 RCT Study of CX-8998 for Essential Tremor – PI – Dr Dalvi Sub PI – Dr Acevedo
Web: https://clinicaltrials.gov/ct2/show/NCT03101241

• PSSV and SQV – Completed and approved from sponsor
• PK (-80) freezer – Sponsor to cover 50% for freezer cost
• The study package is with the 3rd of 4 reviewers (quality management)
• ICF updated with sponsor corrections.
• IRB to be sent after quality management approval

9. A Phase 2A, Double-blind, placebo-controlled, Two-Part Study To Investigate The Safety And Efficacy of increasing doses of DNS 7801 in Parkinson’s Disease (PD) Subjects with motor fluctuations.
Web: https://clinicaltrials.gov/ct2/show/NCT03306329

• INC Research Study #1009659
• CDA Signed. August 17, 2017
• PSSV Completed on Tuesday, October 17, 2017 at 9:30 AM – 5:00 PM

Sponsor reviewed the following topics:

• Assess subject recruitment plans, including subject availability and enrollment strategies.
• Discussed an overview of the study protocol, with emphasis on entry criteria, informed consent requirements, study design, adverse event reporting, and visit requirements.
• Discussed prior sponsor and regulatory audits and their outcome, financial disclosure requirements, and contract and budget issues.
• Discussed source documentation expectations and availability.
• Evaluated site personnel qualifications, roles and current responsibilities, including prior clinical research experience, and familiarity with GCP/ICH guidelines and regulatory requirements.
• Evaluated the suitability of PBNI-WPB for the conduct of the study. This included patient examination areas, as well as diagnostic imaging (e.g MRI, Videographer, EEG), Laboratory, drug and clinical supply storage facilities and study monitoring areas.
• Obtained site personnel contact information.
• Obtained IRB’s meeting schedule, deadlines for submission, timeframe for approval, etc.

Reviewed PBNI-WPB capacity for the Clinical Ink electronic source system.

HUDs – Humanitarian Use Device (HUD) –

• Wingspan
  • Web: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=376103
• Neuroform
  • Web: https://www.accessdata.fda.gov/cdrh_docs/pdf2/h020002b.pdf
• Codman Enterprise
  • Web: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H060001
• LVIS
  • Web: https://www.accessdata.fda.gov/cdrh_docs/pdf13/h130005c.pdf
• Pulserider (IRB review – (Lisa C))
  • Web: https://www.accessdata.fda.gov/cdrh_docs/pdf16/H160002B.pdf