Partial Onset SeizuresPhase 4NCT03288129

Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

A Phase 4 study testing Perampanel in people with Partial Onset Seizures and Secondarily Generalized Seizures, run by Eisai Inc. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 years and older
Conditions the study is for: Partial Onset Seizures, Secondarily Generalized Seizures, Primary Generalized Tonic-Clonic Seizures
What is being tested?: Perampanel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 24 sitesUnited States
Study dates: 23 Aug 2017to 27 Apr 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participants will be male or female and no younger than 4 years of age and be able to swallow perampanel tablets.
Participants must have a diagnosis of epilepsy with POS with or without SGS or with PGTCS. Either of the following must have occurred to support an epilepsy diagnosis:
At least two unprovoked (or reflex) seizures occurring greater than 24 hours apart
One unprovoked (or reflex) seizure with Electroencephalography (EEG) evidence of seizures
Participants who receive perampanel as a first adjunctive therapy must currently have been treated with stable doses of monotherapy with an anti-epileptic drug (AED) for 8 weeks prior to Visit 2 (Week 0), have not previously received adjunctive AED treatment, and must, in the investigator's judgement, be in need of initial adjunctive therapy after failure to control seizures with AED monotherapy, at the optimal dose and duration.
Participants who receive perampanel as monotherapy, who were newly diagnosed (treatment naïve), following the defined diagnosis of epilepsy.
Participants who are currently receiving monotherapy treatment may receive perampanel as monotherapy if, in the investigator's judgment, the participant may benefit from a change in monotherapy treatment. Participants must not have previously received adjunctive AED treatment.
If antidepressants or antianxiety drugs are used, participants must be on a stable dose regimen of these drugs during the 8 weeks before Visit 2 (Week 0).

Who cannot join

Participants should not have previously received or currently be receiving perampanel.
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or hCG test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG); a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Females of childbearing potential who:
Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
Total abstinence (if it is their preferred and usual lifestyle)
An intrauterine device or intrauterine hormone-releasing system

Show all 27Show fewer

An oral contraceptive (with additional barrier method if using contraceptive containing levonorgestrel); participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation
Have a vasectomized partner with confirmed azoospermia
Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, i.e, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.
NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
Presence of or previous history of Lennox-Gastaut syndrome
Presence of non-motor simple partial seizures only
A history of status epilepticus within 1 year before Screening Visit (Visit 1)
Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Screening Visit (Visit 1)
Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 2 (Week 0)
Use of intermittent rescue benzodiazepines (i.e, 1 to 2 doses over a 24-hour period is considered a one time rescue) 2 or more times in the 8-week period prior to Visit 2 (Week 0)
Severe renal insufficiency (defined by estimated glomerular filtration rate of < 30 milliliters per minute [mL/min]) or participants who receive hemodialysis
Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the participant's safety or study conduct NOTE: Stable elevation of liver enzymes, alanine aminotransferase and aspartate aminotransferase due to concomitant medication(s) will be allowed if they are less than 3 times the upper limits of normal.
Hypersensitivity to perampanel or any excipients
Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Participants who are participating in other interventional clinical trial
Participant who are judged to have inadequate cognitive ability for participation in the study (intelligence quotient < 80 or investigator judgment)
Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of screening, as indicated by answering "Yes" to questions 4 and 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)
Any lifetime suicidal behavior based on the C-SSRS
Concomitant use of any form of cannabidiol (CBD)
Planned brain surgery during study participation

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

UNM Health Providers
Albuquerque, New Mexico, 87106
The Regents of The University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
RUSH University Medical Center
Chicago, Illinois, 60612
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke Neurology
Durham, North Carolina, 27710
Michigan State University
East Lansing, Michigan, 48824
JFK Medical Center
Edison, New Jersey, 08820
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55442
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Baptist Health, Nemours Children's Specialty Care
Jacksonville, Florida, 32207
UCSD Epilepsy Center
La Jolla, California, 92393
University of Kentucky
Lexington, Kentucky, 40536
Arkansas Epilepsy Program
Little Rock, Arkansas, 72205
Mount Sinai Medical Center
New York, New York, 10016
Stanford Medical Center
Palo Alto, California, 94304
Barrow Neurological Institute
Phoenix, Arizona, 85013
UC Davis Medical Center
Sacramento, California, 95817
Children's Hospital of San Antonio
San Antonio, Texas, 78207

Other trials in United States

About this study

Official title: Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).

Conditions: Partial Onset Seizures, Secondarily Generalized Seizures, Primary Generalized Tonic-Clonic Seizures
Being tested: Perampanel
Keywords: monotherapy, adjunctive therapy, open-label, multicenter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PerampanelDrug
Also called Fycompa, E2007
film-coated tablets

Study groups in NCT03288129
Study group	Role	What they receive
Perampanel	Experimental	Perampanel will be administered orally once daily (QD) at bedtime. At the beginning of the Titration Period, oral perampanel will start at a dose of 2 milligrams (mg) QD. Doses of perampanel will then be up titrated in increments of 2 mg at no less than 2-week intervals according to the investigator's judgment. At the 4 mg dose, the investigator will confirm whether further dose escalation is needed based on participant response and tolerability. The investigator may adjust dosing further or leave the participant at 4 mg. The maximum dose is 12 mg. During the 39-week Maintenance Period, participants will continue to receive the perampanel dose level that was administered at the end of the Titration Period. Receives: Drug: Perampanel

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.
Measured: Month 3
Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
Measured: Month 6
Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.
Measured: Month 9
Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.
Measured: Month 12

Secondary outcomes (6)

Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period
Seizure-free status was defined as no incidence of seizure during the entire maintenance period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participants does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Measured: Up to 39 weeks of Maintenance Period
Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period
Seizure-free status was defined as no incidence of seizure at 3 months during the Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Measured: Up to 3 months of Maintenance Period
Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period
Seizure-free status was defined as no incidence of seizure at 6 months during Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Measured: Up to 6 months of Maintenance Period
Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy
Percentage of participants who received perampanel as a first adjunctive therapy and converted to perampanel monotherapy were reported.
Measured: Up to 52 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAE)
A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.
Measured: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)
Number of Participants With Treatment-emergent Serious Adverse Events (SAE)
A SAE was defined as any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. A TEAE was defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Measured: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 201727 Apr 2021

First posted19 Sep 2017
Study start23 Aug 2017
Primary completion27 Apr 2021
Study completion27 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Partial Onset SeizuresStudies of the same condition, open and under way.
More trials run by Eisai 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03288129
Sponsor's protocol ID: E2007-G000-410
Other IDs: 2017-001180-20, 2017
Status last verified: Apr 2022
First submitted: 13 Sep 2017
Last updated: 16 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Partial Epilepsy
Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures

All Partial Onset Seizures trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
ClinicalTrials.gov ID: NCT03288129
Acronym / sponsor ID: E2007-G000-410
Conditions: Partial Onset Seizures, Secondarily Generalized Seizures, Primary Generalized Tonic-Clonic Seizures
Keywords: monotherapy, adjunctive therapy, open-label, multicenter
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: 23 Aug 2017 (actual)
Primary completion: 27 Apr 2021 (actual)
Study completion: 27 Apr 2021 (actual)
First posted: 19 Sep 2017 (actual)
Results: Posted 16 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Perampanel	Experimental	Drug: PerampanelPerampanel will be administered orally once daily (QD) at bedtime. At the beginning of the Titration Period, oral perampanel will start at a dose of 2 milligrams (mg) QD. Doses of perampanel will then be up titrated in increments of 2 mg at no less than 2-week intervals according to the investigator's judgment. At the 4 mg dose, the investigator will confirm whether further dose escalation is needed based on participant response and tolerability. The investigator may adjust dosing further or leave the participant at 4 mg. The maximum dose is 12 mg. During the 39-week Maintenance Period, participants will continue to receive the perampanel dose level that was administered at the end of the Titration Period.

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Participants will be male or female and no younger than 4 years of age and be able to swallow perampanel tablets.
Participants must have a diagnosis of epilepsy with POS with or without SGS or with PGTCS. Either of the following must have occurred to support an epilepsy diagnosis:
Participants who receive perampanel as a first adjunctive therapy must currently have been treated with stable doses of monotherapy with an anti-epileptic drug (AED) for 8 weeks prior to Visit 2 (Week 0), have not previously received adjunctive AED treatment, and must, in the investigator's judgement, be in need of initial adjunctive therapy after failure to control seizures with AED monotherapy, at the optimal dose and duration.
Participants who receive perampanel as monotherapy, who were newly diagnosed (treatment naïve), following the defined diagnosis of epilepsy.
Participants who are currently receiving monotherapy treatment may receive perampanel as monotherapy if, in the investigator's judgment, the participant may benefit from a change in monotherapy treatment. Participants must not have previously received adjunctive AED treatment.

Key exclusion criteria (27 listed)

Participants should not have previously received or currently be receiving perampanel.
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or hCG test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG); a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Females of childbearing potential who:
NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
Presence of or previous history of Lennox-Gastaut syndrome

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
PerampanelAlso: Fycompa, E2007film-coated tablets	Drug	Perampanel

Primary outcome

Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment
Time frame: Month 3
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.
Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment
Time frame: Month 6
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment
Time frame: Month 9
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.
Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment
Time frame: Month 12
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.

6 secondary outcomes

Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period
Time frame: Up to 39 weeks of Maintenance Period
Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period
Time frame: Up to 3 months of Maintenance Period
Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period
Time frame: Up to 6 months of Maintenance Period
Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy
Time frame: Up to 52 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Time frame: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)
Number of Participants With Treatment-emergent Serious Adverse Events (SAE)
Time frame: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)

Results and safety

Results posted to the registry on 16 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Perampanel 12 mg	54	32

Primary outcome: Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment

Time frame: Month 3. Number. Unit: percentage of participants

Measure	Perampanel 12 mg n = 54
Value	85.2

Population analysed: The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Primary outcome: Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment

Time frame: Month 6. Number. Unit: percentage of participants

Measure	Perampanel 12 mg n = 54
Value	68.5

Population analysed: The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Primary outcome: Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment

Time frame: Month 9. Number. Unit: percentage of participants

Measure	Perampanel 12 mg n = 54
Value	63.0

Population analysed: The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Primary outcome: Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment

Time frame: Month 12. Number. Unit: percentage of participants

Measure	Perampanel 12 mg n = 54
Value	51.9

Population analysed: The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Perampanel 12 mg	4 of 54 (7.4%)	47 of 54 (87%)	1 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Related trials for Partial Onset Seizures

Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Partial Epilepsy
Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures

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.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Perampanel in people with Partial Onset Seizures and Secondarily Generalized Seizures, run by Eisai Inc. at 24 sites 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 8 inclusion and 27 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 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment (time frame: Month 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03288129.

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 16 May 2022.