Research Trials

Research Trials @ CRC

If interested in any of the following studies, call the research Hotline at (808) 564-6141 or email Study@HawaiiNeuroscience.com

ADVANCE Study Addressing Dementia Via Agitation-Centered Evaluation

This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer’s disease.

Inclusion Criteria:
Diagnosis of probable Alzheimer’s disease
Diagnosis of clinically signification agitation resulting from probable AD

OPUS Study of Natalizumab in Focal Epilepsy

The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.

Inclusion Criteria:
Clinical diagnosis of focal epilepsy, supported by electroencephalogram
Drug-resistant epilepsy, defined as failure of adequate trials of 2 or more antiepileptic drugs
Must have 6 or more seizure during the 6-week baseline period
Must not be seizure free for more than 21 consecutive days

ARISE Study on Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult with Drug-resistant Epilepsy

The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

Inclusion Criteria:
Diagnosis of focal epilepsy at least 3 years before study entry
Failed to control seizure with 4 antiepileptic drugs previously
4 or more spontaneous and observable focal seizures per month

Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects

This is a 12-month safety study to evaluate the safety of repeated doses of NRL-1

Inclusion Criteria:
6 to 65 years old
Clinical diagnosis of epilepsy and while on antiepileptic medication still experiences seizures
Have partial or generalized Epilepsy with motor seizures and seizures with clear alternation of awareness

Study to Assess the Pharmacokinetics and Safety of DBSF in Adult Subjects With Epilepsy

The hypothesis of this study is that DBSF will be safe whether it is given when subjects are not experiencing seizures (Interictal Period A) or experiencing active seizures (ictal/peri-ictal Period B), and that Pharmacokinetic (PK) is not different during or in between the seizures.

Inclusion Criteria:
18 to 65 years old
Body weight of 40 kg to 111 kg
Clinical diagnosis of epilepsy
Frequency of more than 1 seizure every 3 days or more than 10 seizures a month
Taking at least 1 antiepileptic medication

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

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.

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.

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

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

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

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