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CompletedNCT04241965Updated Aug 24, 2022

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

A Phase 1 interventional study of OPC-214870 and Placebo in Epilepsy, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2021, 4 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

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Conditions studied

  • Epilepsy

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03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 16 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • 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.

    Drug: OPC-214870 · Other: Placebo

  • Placebo comparator
    Placebo

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

    Drug: OPC-214870 · Other: Placebo

Interventions

  • DrugOPC-214870

    Tablet(s)

  • OtherPlacebo

    Tablet(s)

06

What researchers measure

Primary outcomes

  1. Change in Standardized Photosensitivity Range (SPR)

    OPC-214870 in comparison to placebo

    Time frame: Up to 3 days

Secondary outcomes

  1. Onset and duration of SPR

    OPC-214870 in comparison to placebo

    Time frame: Up to 3 days

07

Study locations

1 site
  • For additional information regarding sites, contact 844-687-8522
    Ormond Beach, Florida 34174, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04241965
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party
Sponsor
First posted
Jan 27, 2020
Start date
Feb 18, 2020
Primary completion
Oct 11, 2021
Completion
Oct 28, 2021
Last update
Aug 24, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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