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Completed

NCT Number: NCT04252846

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

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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Key information

Conditions

Idiopathic Generalized Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Epilepsy, Idiopathic Generalized Epilepsy, Tonic-Clonic Generalised Tonic-Clonic Seizures Nervous System Diseases Neurologic Manifestations Partial Onset Seizures Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sydvestjysk Sygehus Esbjerg, Esbjerg, Region Syddanmark, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perampanel

Drug

Perampanel oral tablets or oral suspension.

Other names: Fycompa

Primary outcomes

  1. 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.

Secondary outcomes

  1. Retention Rate at Month 6

    Time frame: Month 6

    Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.

  2. Pragmatic Seizure-free Rate at Months 6 and 12

    Time frame: 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).

  3. Completer Seizure-free Rate at Months 6 and 12

    Time frame: 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.

  4. Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12

    Time frame: 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).

  5. 50 Percent (%) Responder Rate at Months 6 and 12

    Time frame: 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.

  6. Seizure Worsening Rate at Months 6 and 12

    Time frame: 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.

  7. Last Dose of Perampanel at Months 6 and 12

    Time frame: Months 6 and 12

  8. Percentage of Participants by Perampanel Dose Titration Speed

    Time frame: Up to Month 12

  9. Duration of Treatment on Perampanel

    Time frame: Up to Month 12

  10. 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

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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