Research and Clinical Trial Unit

Honolulu Campus

2228 Liliha St #304

Honolulu, HI 96817

      

Windward Campus

642 Ulukahiki St #300

Kailua, HI 96734

 
Recruitment Hot Line/Rachel (808) 564-6113
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The Neuroscience Research & Clinical Trial unit at Hawaii Pacific Neuroscience is one of the most sought after clinical trial site in the US for neuroscience conditions because of its reputation for excellence in clinical care and operational excellence in research and clinical trials. Hawaii Pacific Neuroscience is the leading and one of the largest provider of neuroscience care in Hawaii and the practice is growing with over 2500 NEW patients every year. The clinical trial site has a reputation for patient recruitment and retention, standardized streamlined electronic database with close to 10,000 patients in the practice, standardized prescreen procedures. The facility encompasses over 7,000 square feet of office space with 24 exam rooms including dedicated clinical trial facility and exam room including in-house centrifuge, subzero refrigerator, one temperature controlled, locked drug storage room and file storage (short term and long term storage), reception area, private waiting room, large parking area and adequate work space for site and monitor visits. Facility is in same building with overnight medical and nursing care for overnight patients and less than 0.5 mile from emergency room. Facilities are fully handicap accessible and offers cable TV, available Wi-Fi, DVD and book library, ensuring the comfort of patients. Facility is open Monday -Saturday, 8:00am-5:00pm. All subjects can call facilities main number after-hours in case of emergency and will be contacted by an On-Call Physician, otherwise subjects are instructed to dial '911' if an event is life-threatening. Site is available to receive, store and acknowledge study drug in IWRS Monday-Friday. If the designated staff member is not available there is always back-up staff available to receive, store and acknowledge study drug in IWRS Monday-Friday. IP is stored on shelves in a separate room in the office behind a single locked door requiring hard key access. The IP storage room is temperature controlled 7 days/week Monday-Sunday with a min/max digital thermometer. The temperature is manually recorded daily on a paper log five days a week. There is an alarm for temperature excursions. The site IP dispensing practice is to follow protocol procedures regarding IP dispensing. The min/max digital thermometer is calibrated yearly, January 2016 will be the next calibration date. The site has the following equipment: Manual Blood Pressure Cuffs, Digital Weight Scale, -20 Freezer, Ambient Centrifuge, 12 Lead ECG machine.

The equipment listed above is calibrated manually; documented with a sticker on the equipment and documented in a log on site. The site has availability of dry ice daily or weekly and laboratory personnel are IATA certified. Site staff Coordinators have experience with several EDC systems and iMedidata. Site coordinators can comply with eCRF completion guidelines and respond to EDC queries in a timely manner. Site staff has experience with several IWRS systems including BioClinica. The site prefers a wired LAN transmission of ECG and Spirometry data.

Principal Investigators: Kore Liow, MD is a board certified neurologist with over 15 years clinical research experience. In the past 15 years, has served as PI or site PI for over 40 clinical trials in neuroscience including Epilepsy, Dementia, Parkinson’s Disease, stroke studies among others sponsored by the industries, NIH, CDC and others. Dr. Liow has over 20 years’ experience with completion of various rating scales for neurologic disorders in clinical trials. He dedicates over 50% of his time in clinical research. Dr. Liow received his Neurology training at University of Utah and completed a fellowship in Epilepsy Research Branch, NINDS, NIH.

Sub-Investigators (SubI): Panida Piboolnurak, MD is a board certified neurologist with over 10 years of clinical research experience. She has served as an investigator for neuroscience clinical trials including Parkinson’s disease, dementia and others. She completed neurology training at Cornell University and fellowship in Parkinson’s and Movement Disorders at Columbia University in New York and is specially trained in Parkinson’s related ratings like UPDSR and PD Diary for over 10 years. David Kaminskas, MD is a board certified neurologist with special interest in headache and stroke as well as general neurology. Irisa Devine, MD is a board certified pediatric neurologist trained at Mayo Clinic with fellowship training in pediatric epilepsy, neuromuscular diseases, pediatric EEG and EMG. Patricia Borman, MD is a board certified family medicine physician and geriatrician skilled in basic medical exam, EKGs. Tiffany Sandoval, PhD, Licensed neuropsychologist skilled and experienced in ratings in clinical trials. Thomas Harding, PsyD, Licensed neuropsychologist skilled and experienced in ratings in clinical trials.

PI and SubIs are experienced investigators with average of more than 10 years of clinical trial experience in neuroscience.

The PI and SubIs are supported by a team of full time dedicated research staff. Team is managed by a full time dedicated Clinical Research Project Manager who has over 5 years of experience in clinical research and who has served as clinical research coordinator (CRC) for over 60 trials including 2 FDA audits who will oversee a team of CRCs including an APRN and an RN. All staff are cross-trained on all studies so there is no issue with time out of office. PI delegates responsibilities per study protocol and scope of staff. Coordinators usually oversee patient’s visits, with PI supervision and ultimate responsibility. PI is very involved in each visit, completes and reviews the consenting process for most visits. All physical exams completed by PI or Sub-I, delegation log describes in more detail per study. PI is 100% available to research facility, and always available at all CRA visits. PI undergone research fellowship training at NINDS, NIH and has extensive experience with FDA regulated studies and SubIs and staff involved with research has current certificates for ICH-GCP training. PI and Sub-Investigators will have no restrictions related to their professional practices if they participate in this study.

 

 

HPN's Leadership in Bringing Neuroscience Research, Training to Hawaii.

http://jabsom.hawaii.edu/neuroscience-symposium-draws-more-than-100-participants/

 

 

DAYBREAK Study on BACE-I (Beta Secretase-Inhibitor) on Mild Alzheimer’s Disease.

https://clinicaltrials.gov/ct2/show/NCT02783573

The main purpose of this study is to evaluate the efficacy of the disease-modifying drug (beta secretase cleaving enzyme inhibitor) known as LY3314814 for patients with mild Alzheimer’s (AD) disease dementia. The drug is designed to prevent the formation of amyloid plaque and slow the progression of the disease.

Inclusion Criteria:

  • 55 to 85 years old
  • Participant must meet the National Institute on Aging (NIA) and the Alzheimer’s Association (AA) criteria for probably AD dementia
  • Mini-Mental State Examination (MMSE) score of 20 to 26 at screening
  • For diagnosis of mild AD dementia, Clinical Dementia Rating (CDR) global score of 0.5 or 1 with the memory box score greater or equal to 0.5 at screening
  • Evidence of amyloid pathology
  • Reliable study partner whom he/she cohabits or has regular contact

 

 

ITI-007 Study in AGITATION in Alzheimer’s Dementia.

https://clinicaltrials.gov/ct2/show/NCT02817906

This is randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia including Alzheimer’s disease.

Inclusion Criteria:

  • Must be greater than 54 years old
  • Clinical diagnosis of probably Alzheimer’s disease
  • Clinically significant symptoms of agitation secondary to probable Alzheimer’s disease
  • Able to attend outpatient clinic visits with primary caregiver

 

 

YKP3089C021 Study on Partial Onset Seizures.

https://clinicaltrials.gov/ct2/show/NCT02535091

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs other than phenytoin and phenobarbital to further investigate long-term safety.

Inclusion Criteria:

  • 18 to 70 years old at least 30 kg weight
  • Diagnosis of partial epilepsy demonstrated in clinical history or EEG
  • Uncontrolled partial seizures that require additional AED therapy despite current medication
  • Currently on stable antiepileptic treatment regimen
  • CT or MRI scan performed prior to randomization up to 10 years that rules out progressive cause of epilepsy

 

 

A0081105 Study on Generalized Epilepsy

https://clinicaltrials.gov/ct2/show/NCT01747915

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

Inclusion Criteria:

  • Ages 5 to 65 years old
  • Clinical diagnosis of seizures classified as Primary Generalized Tonic-Clonic Seizures (PGTC)
  • Must have had 1 PGTC seizure within 8 weeks prior to screening
  • Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
  • Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic drugs

 

 

COMB157G2301 Study on Relapsing Remitting Multiple Sclerosis

https://clinicaltrials.gov/ct2/show/NCT02792218

A clinical study to compare the efficacy and safety of Ofatumumab administered subcutaneously every 4 weeks versus Teriflunomide administered orally once daily in patients with relapsing multiple sclerosis (MS).

Inclusion Criteria:

  • Ages 18 to 55 years old
  • Clinical diagnosis of Multiple Sclerosis
  • Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis course
  • At least 1 relapse during the previous year or 2 relapses during the past 2 years or a positive Gadolinium-enhanced MRI scan in the previous year
  • Expanded Disability Status Scale of 0 to 5.5

 

 

RESTORE 16306A Study on Neurogenic Orthostatic Hypotension

https://clinicaltrials.gov/ct2/show/NCT02586623

A clinical study to evaluate the time to treatment intervention in patients with Parkinson’s Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) deficiency who have been previously stabilized with Droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH).

Inclusion Criteria:

  • 18 years or older able to stand with/without limited assistance
  • Documented significant drop of standing blood pressure within 3 minutes of standing
  • Clinical diagnosis of symptomatic orthostatic hypotension with PD, MSA, PAF, NDAN, or DBH deficiency
  • A score of 4 or greater on Orthostatic Hypotension Symptom Assessment (OHSA)
  • Patients currently taking Droxidopa must meet separate OHSA score requirements

 

 

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