Idiopathic Generalized EpilepsyNCT04252846
A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
An observational study of Idiopathic Generalized Epilepsy and Partial Onset Seizures, run by Eisai Limited at 36 sites in 7 countries.
Trial summary
The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Idiopathic Generalized Epilepsy, Partial Onset Seizures, Generalised Tonic-Clonic Seizures
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- How many people
- 191 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 20 Jul 2020to 12 Jan 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 300 participants with diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE)
Who may be able to join
- Diagnosis of epilepsy
- History of POS with or without SG or PGTCS associated with IGE
- Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
- Previously treated with 1 or 2 AEDs as monotherapy
- At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency
Who cannot join
- Episode(s) of status epilepticus within the past 6 months before Screening
- Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)
- Previous or current use of perampanel
- Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days
- Hypersensitivity to perampanel or any of the excipients
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
Italy9 sites
Ospedale Policlinico San Martino
Genova
Ospedale di Merano
Merano, Trentino-Alto Adige
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy
AORN A Cardarelli
Naples, Campania
Azienda Ospedaliera Universitaria Federico II
Naples
Ospedale Santa Maria Della Misericordia Di Perugia
Perugia, Umbria
Policlinico Universitario Campus Biomedico Di Roma
Roma
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio
Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia
France8 sites
Centre de consultations Saint-Jean Bâtiment A
Cagnes-sur-Mer
Hôpital Roger Salengro
Lille, Nord
Hopitaux de La Timone
Marseille
Hôpital Robert Debré
Paris
Centre hospitalier de Pau
Pau
Hôpital Pontchaillou
Rennes, Ille-et-Vilaine
Centre Hospitalier Universitaire de Toulouse
Toulouse
CHRU Bretonneau
Tours
Spain7 sites
Hospital Universitari Sagrat Cor Quironsalud
Barcelona
Hospital Universitario Virgen de Las Nieves
Granada
Hospital Regional Universitario de Malaga - Hospital General
Málaga
Hospital Universitario de Donostia
San Sebastián
Hospital Universitario Virgen Macarena
Seville
Hospital Clinico Universitario de Valladolid
Valladolid
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra
Russia6 sites
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
Krasnoyarsk
City Clinical Hospital #1 n.a. N.I.Pirogov
Moscow
Moscow State Medical Stomatological University n.a. A.I. Evdokimov
Moscow
Russian National Research Medical University n.a. N.I.Pirogov
Moscow
City Neurology Center Sibneuromed LLC
Novosibirsk
Regional Treatment and Rehabilitation Center
Tyumen
Portugal3 sites
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon
Centro Hospitalar de São João, E.P.E.
Porto
About this study
Official title: A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.
- Conditions
- Idiopathic Generalized Epilepsy, Partial Onset Seizures, Generalised Tonic-Clonic Seizures
- Being tested
- Perampanel
- Keywords
- Perampanel, Fycompa, Epilepsy, Seizures, Prospective
- Medical subject headings
- Epilepsy, Idiopathic Generalized, Epilepsy, Tonic-Clonic, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called Fycompa
Perampanel oral tablets or oral suspension.
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Participants with a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment. Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate at Month 12
Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.
Measured: Month 12
Secondary outcomes (10)
Retention Rate at Month 6
Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.
Measured: Month 6
Pragmatic Seizure-free Rate at Months 6 and 12
Pragmatic seizure-free rate is defined as the percentage of participants (based on all study participants) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months).
Measured: Months 6 and 12
Completer Seizure-free Rate at Months 6 and 12
Completer seizure-free rate is defined as the percentage of participants (based on a subset of study participants who remain on perampanel treatment at 6 and 12 months) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months), respectively.
Measured: Months 6 and 12
Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12
Seizure frequency change will be measured at 6 months (averaged over the previous 3 months) and at 12 months (averaged over the previous 6 months).
Measured: Months 6 and 12
50 Percent (%) Responder Rate at Months 6 and 12
50% responder rate is defined as the percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the12-month visit) relative to baseline.
Measured: Months 6 and 12
Seizure Worsening Rate at Months 6 and 12
Seizure worsening rate is defined as the percentage of participants with >=10% increase in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the 12-month visit) relative to baseline.
Measured: Months 6 and 12
Last Dose of Perampanel at Months 6 and 12
Measured: Months 6 and 12
Percentage of Participants by Perampanel Dose Titration Speed
Measured: Up to Month 12
Duration of Treatment on Perampanel
Measured: Up to Month 12
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity
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 posted5 Feb 2020
- Study start20 Jul 2020
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Generalized 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252846
- Sponsor's protocol ID
- E2007-M044-512
- Status last verified
- Dec 2022
- First submitted
- 31 Jan 2020
- Last updated
- 9 Feb 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 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
- ClinicalTrials.gov ID
- NCT04252846
- Acronym / sponsor ID
- E2007-M044-512
- Conditions
- Idiopathic Generalized Epilepsy, Partial Onset Seizures, Generalised Tonic-Clonic Seizures
- Keywords
- Perampanel, Fycompa, Epilepsy, Seizures, Prospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 5 Feb 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.
The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | – | Drug: PerampanelParticipants with a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 300 participants with diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE)
Key inclusion criteria (5 listed)
- Diagnosis of epilepsy
- History of POS with or without SG or PGTCS associated with IGE
- Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
- Previously treated with 1 or 2 AEDs as monotherapy
- At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency
Key exclusion criteria (5 listed)
- Episode(s) of status epilepticus within the past 6 months before Screening
- Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)
- Previous or current use of perampanel
- Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days
- Hypersensitivity to perampanel or any of the excipients
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: FycompaPerampanel oral tablets or oral suspension. | Drug | Perampanel |
Primary outcome
Retention Rate at Month 12
Time frame: Month 12
Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.
10 secondary outcomes
Retention Rate at Month 6
Time frame: Month 6
Pragmatic Seizure-free Rate at Months 6 and 12
Time frame: Months 6 and 12
Completer Seizure-free Rate at Months 6 and 12
Time frame: Months 6 and 12
Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12
Time frame: Months 6 and 12
50 Percent (%) Responder Rate at Months 6 and 12
Time frame: Months 6 and 12
Seizure Worsening Rate at Months 6 and 12
Time frame: Months 6 and 12
Last Dose of Perampanel at Months 6 and 12
Time frame: Months 6 and 12
Percentage of Participants by Perampanel Dose Titration Speed
Time frame: Up to Month 12
Duration of Treatment on Perampanel
Time frame: Up to Month 12
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs 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 9 Feb 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.
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Generalized Epilepsy and Partial Onset Seizures, run by Eisai Limited at 36 sites in 7 countries.
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 5 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 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Italy, France, Spain, Russia, Portugal and 2 more countries. 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?
Retention Rate at Month 12 (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 9 Feb 2023.