EpilepsyPhase 4NCT02726074
Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
A Phase 4 study testing Perampanel in people with Epilepsy, run by Eisai Korea Inc. at 6 sites in South Korea.
Trial summary
This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of perampanel added to monotherapy for partial onset seizures with or without secondarily generalized seizures (total seizures). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Perampanel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 3 May 2016to 26 Apr 2018
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
- Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
- Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
- Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
- If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)
Who cannot join
- Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
- Presence of previous history of Lennox-Gastaut syndrome
- Presence of nonmotor simple partial seizures only
- Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
- A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
- 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 Visit 1 (Week 0)
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- 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 [EEG]) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 1 (Week 0)
- Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week 0)
- Participant who is participating in other intervention clinical trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Study site
Busan
Study site
Daegu
Study site
Daejeon
Study site
Gwangju
Study site
Seongnam
Study site
Seoul
About this study
Official title: Multicenter, Open-label Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Patients With Partial Onset Seizures With or Without Secondary Generalization
This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of perampanel added to monotherapy for partial onset seizures with or without secondarily generalized seizures (total seizures).
Read the detailed description
This multi-center, open-label, single-arm study evaluating the efficacy of perampanel added to monotherapy for partial onset seizures consists of 2 periods: Titration Period (12 weeks) and Maintenance Period (24 weeks). During the Titration Period, participants will begin receiving perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study.
- Conditions
- Epilepsy
- Being tested
- Perampanel
- Keywords
- epilepsy, partial-onset seizures, secondarily generalized seizures
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called E2007
| Study group | Role | What they receive |
|---|---|---|
| Perampanel 12 mg | Experimental | During the Titration Period, participants will receive perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study. Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
The 50% responder rate was defined as the percentage of participants who achieved at least 50% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
Measured: Baseline up to Week 36
Secondary outcomes (8)
75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
The 75% responder rate was defined as the percentage of participants who achieved at least 75% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
Measured: Baseline up to Week 36
100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization
The 100% responder rate was defined as the percentage of participants who achieved at least 100% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
Measured: Baseline up to Week 36
Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period
Percent change in the frequency of partial onset seizure with or without secondary generalization was defined as the percent reduction in seizure frequency from baseline to titration period and maintenance period. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency.
Measured: Weeks 12 and 36
50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures
The 50% responder rate was defined as the percentage of participants who have achieved at least a 50% reduction from baseline in the frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
Measured: Baseline up to Week 36
75% Responder Rate in Secondary GTC Seizures
The 75% responder rate was defined as the percentage of participants who achieved at least a 75% reduction from baseline in seizure frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
Measured: Baseline up to Week 36
100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures
The 100% responder rate was defined as the percentage of participants who have at least a 100% reduction from baseline in the frequency of secondary GTC seizures during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
Measured: Baseline up to Week 36
Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period
Percent change in the frequency of secondary GTC seizure was defined as the percent reduction in seizure frequency from baseline to Titration Period and Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency.
Measured: Weeks 12 and 36
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: From the first dose of investigational product to the last visit or 28 days after the last dose (up to 1 year 11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start3 May 2016
- Primary completion26 Apr 2018
- Study completion26 Apr 2018
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 EpilepsyStudies of the same condition, open and under way.
- 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726074
- Sponsor's protocol ID
- E2007-M065-412
- Status last verified
- Dec 2019
- First submitted
- 24 Mar 2016
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Patients With Partial Onset Seizures With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT02726074
- Acronym / sponsor ID
- E2007-M065-412
- Conditions
- Epilepsy
- Keywords
- epilepsy, partial-onset seizures, secondarily generalized seizures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2016 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of perampanel added to monotherapy for partial onset seizures with or without secondarily generalized seizures (total seizures).
Detailed description
This multi-center, open-label, single-arm study evaluating the efficacy of perampanel added to monotherapy for partial onset seizures consists of 2 periods: Titration Period (12 weeks) and Maintenance Period (24 weeks). During the Titration Period, participants will begin receiving perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel 12 mg | Experimental | Drug: PerampanelDuring the Titration Period, participants will receive perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
- Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
- Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
- Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
- If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)
Key exclusion criteria (10 listed)
- Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
- Presence of previous history of Lennox-Gastaut syndrome
- Presence of nonmotor simple partial seizures only
- Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
- A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
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: E2007 | Drug | Perampanel 12 mg |
Primary outcome
50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
Time frame: Baseline up to Week 36
The 50% responder rate was defined as the percentage of participants who achieved at least 50% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
8 secondary outcomes
75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
Time frame: Baseline up to Week 36
100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization
Time frame: Baseline up to Week 36
Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period
Time frame: Weeks 12 and 36
50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures
Time frame: Baseline up to Week 36
75% Responder Rate in Secondary GTC Seizures
Time frame: Baseline up to Week 36
100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures
Time frame: Baseline up to Week 36
Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period
Time frame: Weeks 12 and 36
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of investigational product to the last visit or 28 days after the last dose (up to 1 year 11 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
6 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 Epilepsy, run by Eisai Korea Inc. at 6 sites in South Korea.
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 5 inclusion and 10 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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 5 Feb 2020). 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?
50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization (time frame: Baseline up to Week 36). 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 5 Feb 2020.