- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04241965
A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870
August 19, 2022 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Phase 1b, Single-blind, Placebo-controlled, Adaptive Design, Outpatient Trial to Assess the Effects of Single Oral Tablet Doses of OPC-214870 on Photic-induced Paroxysmal Electroencephalogram Responses in Subjects Who Have Demonstrated Photoepileptiform Discharges on Electroencephalogram With or Without Seizures
Despite availability of several antiepileptic drugs (AEDs), in one-third of patients, epilepsy remains uncontrolled with AEDs.
There is a need to develop new approaches to improve the existing medications to relieve patients' epilepsy, and OPC-214870 is being studied for this purpose.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Ormond Beach, Florida, United States, 34174
- For additional information regarding sites, contact 844-687-8522
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects between 18 and 64 years of age, inclusive.
- Body mass index (BMI) between 18 and 40 kg/m^2, inclusive.
- Subjects with a diagnosis and history of photoparoxysmal response on EEG.
- Subjects must be stable for 1 month prior to screening. Stable is defined as having no change in concomitant therapy and no worsening in the opinion of the investigator.
- Subjects may be treatment-naïve to AEDs or currently treated with up to 3 AEDs.
- Subjects must have a reproducible standardized photosensitivity range on EEG of at least 3 points in at least 1 eye condition.
- Subjects who agree to remain abstinent, or practice double-barrier forms of birth control, from trial to screening through 90 days after the last dose of IMP, OR males and females of non-childbearing potential who are documented as sterile (i.e. male subjects who have undergone bilateral orchidectomy and female subjects who have undergone bilateral oophorectomy, bilateral salpingectomy, or hysterectomy, or who have been postmenopausal for at least 12 months.
Exclusion Criteria:
- History of non-epileptic seizures
- History of status epilepticus in the past 5 years
- An active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease, or any CNS disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results.
- Positive urine drug screen for substance of abuse or upon check in to the trial site. Benzodiazepines are excluded as a drug of abuse, but are allowed as rescue medication or when part of subject's stable concomitant medication at enrollment.
- History of drug and/or alcohol abuse within 24 months prior to screening.
- Consumption of grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 7 days prior to dosing.
- Consumption of more than 1 alcoholic drink within 24 hours prior to dosing. Food and beverages containing methylxanthines (caffeinated coffee, caffeinated tea, caffeinated soda, and chocolate) must remain stable throughout the trial.
- Extreme physical activity within 24 hours before screening and visit
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP
- Subject having taken an investigational drug within 30 days preceding screening.
- Use of over-the-counter drugs, herbal medicines, or vitamin supplements within 14 days or 5 half-lives, whichever is longer, prior to dosing and antibiotics within 30 days prior to dosing.
- Subjects who had neurosurgery in last 6 months.
- Subjects on a ketogenic diet.
- History of significant sleep disorders, or any disorder or activity that causes sleep deprivation.
- Subjects who work "night shifts"
- Subjects with uncontrolled sleep disorders; subjects should be on a stable dose of sleep medications.
- History of, or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV), and/or HIV antibodies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention 1
Single dose; up to 400 mg capsule; adaptive dosage determined by initial dosing from cohort 1.Potential for a matching placebo dose to be administered.
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Tablet(s)
Tablet(s)
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Placebo Comparator: Placebo
Single dose; potential for a matching OPC-214870 dose to be administered.
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Tablet(s)
Tablet(s)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Standardized Photosensitivity Range (SPR)
Time Frame: Up to 3 days
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OPC-214870 in comparison to placebo
|
Up to 3 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset and duration of SPR
Time Frame: Up to 3 days
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OPC-214870 in comparison to placebo
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Up to 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2020
Primary Completion (Actual)
October 11, 2021
Study Completion (Actual)
October 28, 2021
Study Registration Dates
First Submitted
January 23, 2020
First Submitted That Met QC Criteria
January 23, 2020
First Posted (Actual)
January 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2022
Last Update Submitted That Met QC Criteria
August 19, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 325-201-00003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Small studies with less than 25 participants are excluded from data sharing.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication.
There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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