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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04252846
Registration number
NCT04252846
Ethics application status
Date submitted
31/01/2020
Date registered
5/02/2020
Date last updated
9/02/2023
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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E2007-M044-512
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Generalized Epilepsy
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Partial Onset Seizures
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Generalised Tonic-Clonic Seizures
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Perampanel
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.
Treatment: Drugs: Perampanel
Perampanel oral tablets or oral suspension.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Retention Rate at Month 12
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Assessment method [1]
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Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.
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Timepoint [1]
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Month 12
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Secondary outcome [1]
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Retention Rate at Month 6
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Assessment method [1]
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Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.
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Timepoint [1]
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Month 6
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Secondary outcome [2]
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Pragmatic Seizure-free Rate at Months 6 and 12
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Assessment method [2]
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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).
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Timepoint [2]
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Months 6 and 12
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Secondary outcome [3]
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Completer Seizure-free Rate at Months 6 and 12
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Assessment method [3]
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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.
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Timepoint [3]
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Months 6 and 12
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Secondary outcome [4]
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Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12
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Assessment method [4]
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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).
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Timepoint [4]
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Months 6 and 12
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Secondary outcome [5]
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50 Percent (%) Responder Rate at Months 6 and 12
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Assessment method [5]
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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.
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Timepoint [5]
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Months 6 and 12
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Secondary outcome [6]
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Seizure Worsening Rate at Months 6 and 12
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Assessment method [6]
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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.
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Timepoint [6]
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Months 6 and 12
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Secondary outcome [7]
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Last Dose of Perampanel at Months 6 and 12
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Assessment method [7]
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Timepoint [7]
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Months 6 and 12
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Secondary outcome [8]
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Percentage of Participants by Perampanel Dose Titration Speed
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Assessment method [8]
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Timepoint [8]
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Up to Month 12
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Secondary outcome [9]
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Duration of Treatment on Perampanel
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Assessment method [9]
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Timepoint [9]
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Up to Month 12
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Secondary outcome [10]
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Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity
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Assessment method [10]
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Timepoint [10]
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Up to Month 12
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Eligibility
Key inclusion criteria
1. Diagnosis of epilepsy
2. History of POS with or without SG or PGTCS associated with IGE
3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12
months
4. Previously treated with 1 or 2 AEDs as monotherapy
5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate
baseline seizure frequency
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Episode(s) of status epilepticus within the past 6 months before Screening
2. Previously treated with 2 or more AEDs in combination (other than during
cross-titration between AED monotherapies)
3. 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
4. Hypersensitivity to perampanel or any of the excipients
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/01/2023
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Sample size
Target
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Accrual to date
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Final
191
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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South Denmark
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France
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Ille-et-Vilaine
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France
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Nord
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France
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Cagnes-sur-Mer
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France
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Marseille
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France
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Paris
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France
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Pau
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France
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Toulouse
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France
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Tours
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Germany
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Berlin
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Germany
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Ulm
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Italy
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Campania
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Trentino-Alto Adige
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Italy
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Umbria
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Italy
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Genova
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Italy
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Napoli
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Italy
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Roma
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Tyumen
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Spain
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Pontevedra
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Málaga
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Spain
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San Sebastián
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Spain
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Sevilla
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Spain
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Valladolid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eisai Limited
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04252846
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04252846
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