SeizuresNCT04202159
A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures
An observational study of Seizures, run by Eisai GmbH at 34 sites in Germany.
Trial summary
The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizures
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- How many people
- 187 participants
- Where
- 34 sitesGermany
- Study dates
- 21 Jan 2020to 31 Mar 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with PGTC or SGTC seizures.
Who may be able to join
- Confirmed diagnosis of epilepsy with PGTC or SGTC seizures based on focal or idiopathic generalized epilepsy
- Active epilepsy with GTC seizures, demonstrated by the occurrence of at least 1 GTC seizure within 3 months before inclusion
- The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study
- Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC
- Perampanel must either be newly administered as the only add-on treatment to a current antiepileptic drug (AED) monotherapy or must be planned to substitute one of two AEDs of a current dual therapy planned to be stopped within 2 months after initiation of treatment with perampanel. It will be specified which AED is planned to be substituted by perampanel upon inclusion. It is assumed that participants start treatment with perampanel closely after the baseline visit. Retrospective inclusions will be allowed, but only if the time between the initiation of perampanel treatment and inclusion does not exceed 7 calendar days. In this case, the baseline visit documentation should reflect the situation (including seizure situation 3 months before baseline and baseline medication) to the date perampanel treatment was initiated
Who cannot join
- Participants with known psychogenic non-epileptic seizures
- The participant had already received perampanel in the past
- Simultaneous participation in an interventional clinical study and/or taking an investigational drug
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Germany34 sites
Eisai Trial Site #51
Aalen
Eisai Trial Site #12
Berlin
Eisai Trial Site #43
Berlin
Eisai Trial Site #15
Bernau
Eisai Trial Site #8
Bielefeld
Eisai Trial Site #53
Bochum
Eisai Trial Site #38
Bonn
Eisai Trial Site #9
Bonn
Eisai Trial Site #25
Damp
Eisai Trial Site #48
Dortmund
Eisai Trial Site #27
Dresden
Eisai Trial Site #50
Dresden
Eisai Trial Site #7
Erlangen
Eisai Trial Site #44
Friedrichshafen
Eisai Trial Site #4
Greifswald
Eisai Trial Site #21
Hamburg
Eisai Trial Site #47
Hamburg
Eisai Trial Site #14
Jena
Eisai Trial Site #18
Kiel
Eisai Trial Site #54
Kiel
Eisai Trial Site #1
Kork
Eisai Trial Site #24
Leipzig
Eisai Trial Site #28
Lübeck
Eisai Trial Site #26
Magdeburg
Eisai Trial Site #13
Mainz
Eisai Trial Site #36
Mittweida
Eisai Trial Site #42
Nierstein
Eisai Trial Site #2
Radeberg
Eisai Trial Site #16
Ravensburg
Eisai Trial Site #23
Regensburg
Eisai Trial Site #46
Remscheid
Eisai Trial Site #3
Tübingen
Eisai Trial Site #37
Ulm
Eisai Trial Site #40
Weil der Stadt
About this study
Official title: PERPRISE: A Prospective Non-interventional Study Evaluating the Effectiveness of Perampanel (Fycompa®) as Only Add-on Treatment in Patients With Primary or Secondarily Generalized Tonic-clonic Seizures
The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.
- Conditions
- Seizures
- Being tested
- Perampanel
- Keywords
- E2007, Perampanel, Fycompa, Primary generalized tonic-clonic seizures, Secondarily generalized tonic-clonic seizures
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called E2007, Fycompa
Perampanel tablets.
PerampanelDrug
Also called E2007, Fycompa
Perampanel oral suspension.
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Participants with PGTC or SGTC seizures may receive perampanel tablets or oral suspension as only add-on therapy based on physicians decision in accordance with summary of product characteristics (SmPC) and will be observed at baseline, 6 months (intermediate visit), and 12 months (final visit). 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 at Month 12 (Retention Rate)
The retention rate is defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.
Measured: Month 12
Secondary outcomes (3)
Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate)
The retention rate is defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
Measured: Month 6
Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12
Measured: Month 12
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity
AEs will be graded on a 3-point scale that is mild (discomfort noticed, but no disruption of normal daily activity), moderate (discomfort sufficient to reduce or affect normal daily activity), and severe (incapacitating, with inability to work or to perform normal daily activity).
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start21 Jan 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202159
- Sponsor's protocol ID
- E2007-M049-509
- Status last verified
- Aug 2023
- First submitted
- 16 Dec 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERPRISE: A Prospective Non-interventional Study Evaluating the Effectiveness of Perampanel (Fycompa®) as Only Add-on Treatment in Patients With Primary or Secondarily Generalized Tonic-clonic Seizures
- ClinicalTrials.gov ID
- NCT04202159
- Acronym / sponsor ID
- E2007-M049-509
- Conditions
- Seizures
- Keywords
- E2007, Perampanel, Fycompa, Primary generalized tonic-clonic seizures, Secondarily generalized tonic-clonic seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Eisai GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 17 Dec 2019 (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.
The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | – | Drug: PerampanelParticipants with PGTC or SGTC seizures may receive perampanel tablets or oral suspension as only add-on therapy based on physicians decision in accordance with summary of product characteristics (SmPC) and will be observed at baseline, 6 months (intermediate visit), and 12 months (final visit). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with PGTC or SGTC seizures.
Key inclusion criteria (5 listed)
- Confirmed diagnosis of epilepsy with PGTC or SGTC seizures based on focal or idiopathic generalized epilepsy
- Active epilepsy with GTC seizures, demonstrated by the occurrence of at least 1 GTC seizure within 3 months before inclusion
- The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study
- Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC
- Perampanel must either be newly administered as the only add-on treatment to a current antiepileptic drug (AED) monotherapy or must be planned to substitute one of two AEDs of a current dual therapy planned to be stopped within 2 months after initiation of treatment with perampanel. It will be specified which AED is planned to be substituted by perampanel upon inclusion. It is assumed that participants start treatment with perampanel closely after the baseline visit. Retrospective inclusions will be allowed, but only if the time between the initiation of perampanel treatment and inclusion does not exceed 7 calendar days. In this case, the baseline visit documentation should reflect the situation (including seizure situation 3 months before baseline and baseline medication) to the date perampanel treatment was initiated
Key exclusion criteria (3 listed)
- Participants with known psychogenic non-epileptic seizures
- The participant had already received perampanel in the past
- Simultaneous participation in an interventional clinical study and/or taking an investigational drug
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, FycompaPerampanel tablets. | Drug | Perampanel |
| PerampanelAlso: E2007, FycompaPerampanel oral suspension. | Drug | Perampanel |
Primary outcome
Percentage of Participants Remaining on Perampanel at Month 12 (Retention Rate)
Time frame: Month 12
The retention rate is defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.
3 secondary outcomes
Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate)
Time frame: Month 6
Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12
Time frame: Month 12
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity
Time frame: Up to Month 12
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 3 Aug 2023.
- 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/.
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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.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures, run by Eisai GmbH at 34 sites in Germany.
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 3 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany. 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.
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?
Percentage of Participants Remaining on Perampanel at Month 12 (Retention Rate) (time frame: Month 12). 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 3 Aug 2023.