A Study to Investigate Dosage, Effectiveness, and Safety... | NCT04252846

Studies
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

NCT04252846

Sponsor

Eisai Limited

Status

Completed

Last Update Posted

Feb 9, 2023Actual

Enrollment

191Actual

Phase

Not provided

Conditions

Idiopathic Generalized Epilepsy
Partial Onset Seizures
Generalised Tonic-Clonic Seizures

Interventions

Perampanel

Countries

Denmark
France
Germany
Italy
Portugal
Russia
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2020Actual

Primary Completion Date

Jan 12, 2023Actual

Completion Date

Jan 12, 2023Actual

First Submitted Date

Jan 31, 2020

First Submission Date that Met QC Criteria

Jan 31, 2020

First Posted Date

Feb 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2023

Last Update Posted Date

Feb 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

191Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Perampanel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Perampanel	Drug	Perampanel oral tablets or oral suspension.	Perampanel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention Rate at Month 12	Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.	Month 12

Secondary Outcomes

Measure	Description	Time Frame
Retention Rate at Month 6	Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.	Month 6
Pragmatic Seizure-free Rate at Months 6 and 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Approximately 300 participants with diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE)

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Sydvestjysk Sygehus Esbjerg		Esbjerg	Region Syddanmark		Denmark
Hôpital Pontchaillou

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
C562694	Epilepsy, Idiopathic Generalized
D004830	Epilepsy, Tonic-Clonic
D004827	Epilepsy
D012640	Seizures

ID	Term
D004829	Epilepsy, Generalized
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms