A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870

NCT04241965 | Completed Phase 1 FDA Drug

• 1 other identifier: 325-201-00003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Change in Standardized Photosensitivity Range (SPR)

  OPC-214870 in comparison to placebo

  Up to 3 days

Secondary Outcomes (1)

• Onset and duration of SPR

  Up to 3 days

Study Arms (2)

Intervention 1

EXPERIMENTAL

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.

Drug: OPC-214870; Other: Placebo

Placebo

PLACEBO COMPARATOR

Single dose; potential for a matching OPC-214870 dose to be administered.

Drug: OPC-214870; Other: Placebo

Interventions

OPC-214870 DRUG

Tablet(s)

Intervention 1; Placebo

Placebo OTHER

Tablet(s)

Intervention 1; Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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"

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

For additional information regarding sites, contact 844-687-8522

Ormond Beach, Florida, 34174, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: February 18, 2020
• Primary Completion: October 11, 2021
• Study Completion: October 28, 2021
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (1)