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

Cenobamate Adjunctive Therapy in PGTC Seizures

This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects will continue to take their usual AEDs and receive either cenobamate or placebo. Subjects will have a 50% chance or receiving cenobamate or placebo (sugar pill). Subjects will initially receive 12.5 mg of cenobamate or placebo (study drug) and increase the dose every two weeks until they reach a target dose of 200 mg. Subjects will take study drug at approximately the same time in the morning (once a day) with or without food. If tolerability issues arise, dosing can be changed to evening. Also, once a subject reaches 200 mg of study drug, the dose can be decreased one time to 150 mg, if necessary. The treatment period is 22 weeks and there is a 3 week follow up period, which includes a one week decrease in study drug to 100 mg prior to stopping. Subjects who complete may be eligible for an extension study and will not have to complete the follow up period. Subjects will track their seizure types and frequency in a diary throughout the study.

Inclusion Criteria:
Subject is male or female and aged ≥18 years.
Written informed consent signed by the subject or legal guardian
Subject has a clinical diagnosis of PGTC seizures
Subject experiences at least 3 PGTC seizures in 12 weeks during the Pre-Randomization Period.
Subject has had a routine electroencephalogram (EEG) within 5 years prior to Visit1
Subject has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to Visit 1
Subject is currently receiving 1 to a maximum of 3 concomitant AEDs with fixed dosing regimens for a minimum of 30 days prior to Visit 1
Subject with an implanted vagal nerve or deep brain stimulator will be allowed if the stimulator was implanted at least 5 months prior to Visit 1.
Subject taking a ketogenic diet will be allowed as long as the diet has been stable for at least 3 months prior to Visit 1

XEN1101 as Adjunctive Therapy in Focal Epilepsy

The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy.

Inclusion Criteria:
Patient must be 18 Years to 75 Years old.
Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
BMI <35 kg/m2
Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017)
Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the study
Must be willing to comply with the contraception requirements
Able to keep accurate seizure diaries

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Inclusion Criteria:
Patient must be 18 Years and older
Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
Written informed consent

ACP-103 to Treat Parkinson's Disease

This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson’s disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinson’s disease.

Inclusion Criteria:
Patient must be between the ages of 30 and 80 (inclusive)
Patient has been diagnosed with idiopathic Parkinson’s disease based on the presence of a characteristic clinical history and neurological findings
Patient has relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations.
Patient is willing to adhere to protocol requirements as evidenced by written, informed consent.

BAN2401 CLARITY IV MonoconalAb

This study will be conducted to evaluate the efficacy of BAN2401 in participants with early Alzheimer’s disease (EAD) by determining the superiority of BAN2401 compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of BAN2401 in participants with EAD in the Extension Phase.

Inclusion Criteria:
Must be 50 Years to 90 Years old
Diagnosis of Mild Cognitive Impairment (MCI) due to Alzheimer’s disease
Diagnosis of  Mild Alzheimer’s disease dementia
Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II (WMS-IV LMII)
Positive biomarker for brain amyloid pathology
Male or female participants aged greater than or equal to (>=)50 and <=90 years, at the time of informed consent
Mini mental state examination (MMSE) score greater than or equal to 22 at Screening and Baseline and less than or equal to 30 at Screening and Baseline
Body mass index (BMI) greater than 17 and less than 35 at Screening
If receiving an approved Alzheimer’s disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer’s disease, must be on a stable dose for at least 12 weeks prior to Baseline. Treatment-naïve participants for Alzheimer’s disease can be entered into the study. Unless otherwise stated, participants must have been on stable doses of all other (ie, non-Alzheimer’s disease-related) permitted concomitant medications for at least 4 weeks prior to Baseline.

Elebesestat (E2609) MISSIONAD2- BACE Inhibitor (MCI & Early AD)

The name of this trial is MissionAD2. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer’s Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for end points for the studies E2609-G000-301 (NCT02956486) and E2609-G000-302 (NCT03036280) will be pooled.

Inclusion Criteria:
Must be 50 Years to 85 Years old
Mild cognitive impairment due to AD or mild AD dementia including
1. MMSE score equal to or greater than 24
2. CDR global score of 0.5
3. CDR Memory Box score of 0.5 or greater
Impaired episodic memory confirmed by a list learning task
Positive biomarker for brain amyloid pathology as indicated by either amyloid PET or CSF AD assessment or both

CNP 520(Generations 2)

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

Inclusion Criteria:
Consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid.
Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential
Cognitively unimpaired as evaluated by memory tests performed at screening.
Participant’s willingness to have a study partner.
Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging).

BIIB076 Novel TAU binding- humanized Monoclonal Antibodies

The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer’s disease (AD). A secondary objective of the study for both healthy volunteers and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076 after single-dose administration. Another secondary objective is to evaluate the immunogenicity of BIIB076 in serum after single-dose administration.

Inclusion Criteria:
Must be 50 Years to 80 Years of age

Healthy Participants
Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.

Participants with Alzheimer’s Disease (AD)
Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD according to the National Institutes of Aging-Alzheimer’s Association [McKhann 2011], and in addition must have the following:
Clinical Dementia Rating (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD.
CDR Memory Box Score of ≥0.5.
Mini-Mental State Examination score between 18 and 30 (inclusive) at Screening.
Must have amyloid beta positivity confirmed at Screening

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

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

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