EpilepsyPhase 1NCT04241965
A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870
A Phase 1 study testing OPC-214870 in people with Epilepsy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- OPC-214870
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 28 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding sites, contact 844-687-8522
Ormond Beach, Florida, 34174
About this study
Official title: 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.
- Conditions
- Epilepsy
- Being tested
- OPC-214870, Placebo
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-214870Drug
Tablet(s)
PlaceboOther
Tablet(s)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: OPC-214870; Other: Placebo |
| Placebo | Placebo comparator | Single dose; potential for a matching OPC-214870 dose to be administered. Receives: Drug: OPC-214870; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Standardized Photosensitivity Range (SPR)
OPC-214870 in comparison to placebo
Measured: Up to 3 days
Secondary outcomes (1)
Onset and duration of SPR
OPC-214870 in comparison to placebo
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start18 Feb 2020
- Primary completion11 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241965
- Sponsor's protocol ID
- 325-201-00003
- Status last verified
- Aug 2022
- First submitted
- 23 Jan 2020
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04241965
- Acronym / sponsor ID
- 325-201-00003
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Drug: OPC-214870, Other: PlaceboSingle dose; up to 400 mg capsule; adaptive dosage determined by initial dosing from cohort 1.Potential for a matching placebo dose to be administered. |
| Placebo | Placebo comparator | Drug: OPC-214870, Other: PlaceboSingle dose; potential for a matching OPC-214870 dose to be administered. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPC-214870Tablet(s) | Drug | Intervention 1, Placebo |
| PlaceboTablet(s) | Other | Intervention 1, Placebo |
Primary outcome
Change in Standardized Photosensitivity Range (SPR)
Time frame: Up to 3 days
OPC-214870 in comparison to placebo
1 secondary outcome
Onset and duration of SPR
Time frame: Up to 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPC-214870 in people with Epilepsy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Standardized Photosensitivity Range (SPR) (time frame: Up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.