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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
E2007-M044-512
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Generalized Epilepsy 0 0
Partial Onset Seizures 0 0
Generalised Tonic-Clonic Seizures 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Retention Rate at Month 12
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Retention Rate at Month 6
Timepoint [1] 0 0
Month 6
Secondary outcome [2] 0 0
Pragmatic Seizure-free Rate at Months 6 and 12
Timepoint [2] 0 0
Months 6 and 12
Secondary outcome [3] 0 0
Completer Seizure-free Rate at Months 6 and 12
Timepoint [3] 0 0
Months 6 and 12
Secondary outcome [4] 0 0
Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12
Timepoint [4] 0 0
Months 6 and 12
Secondary outcome [5] 0 0
50 Percent (%) Responder Rate at Months 6 and 12
Timepoint [5] 0 0
Months 6 and 12
Secondary outcome [6] 0 0
Seizure Worsening Rate at Months 6 and 12
Timepoint [6] 0 0
Months 6 and 12
Secondary outcome [7] 0 0
Last Dose of Perampanel at Months 6 and 12
Timepoint [7] 0 0
Months 6 and 12
Secondary outcome [8] 0 0
Percentage of Participants by Perampanel Dose Titration Speed
Timepoint [8] 0 0
Up to Month 12
Secondary outcome [9] 0 0
Duration of Treatment on Perampanel
Timepoint [9] 0 0
Up to Month 12
Secondary outcome [10] 0 0
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity
Timepoint [10] 0 0
Up to Month 12

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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/01/2023
Sample size
Target
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Limited
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04252846
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04252846