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Completed

NCT Number: NCT04202159

A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures

The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Trial Site #51, Aalen, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of epilepsy with PGTC or SGTC seizures based on focal or idiopathic generalized epilepsy
  • Active epilepsy with GTC seizures, demonstrated by the occurrence of at least 1 GTC seizure within 3 months before inclusion
  • The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study
  • Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC
  • Perampanel must either be newly administered as the only add-on treatment to a current antiepileptic drug (AED) monotherapy or must be planned to substitute one of two AEDs of a current dual therapy planned to be stopped within 2 months after initiation of treatment with perampanel. It will be specified which AED is planned to be substituted by perampanel upon inclusion. It is assumed that participants start treatment with perampanel closely after the baseline visit. Retrospective inclusions will be allowed, but only if the time between the initiation of perampanel treatment and inclusion does not exceed 7 calendar days. In this case, the baseline visit documentation should reflect the situation (including seizure situation 3 months before baseline and baseline medication) to the date perampanel treatment was initiated

Exclusion criteria

  • Participants with known psychogenic non-epileptic seizures
  • The participant had already received perampanel in the past
  • Simultaneous participation in an interventional clinical study and/or taking an investigational drug

Treatment and study plan

perampanel

Drug

Perampanel tablets.

Other names: E2007, Fycompa

Primary outcomes

  1. Percentage of Participants Remaining on Perampanel at Month 12 (Retention Rate)

    Time frame: Month 12

    The retention rate is defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.

Secondary outcomes

  1. Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate)

    Time frame: Month 6

    The retention rate is defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.

  2. Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12

    Time frame: Month 12

  3. Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity

    Time frame: Up to Month 12

    AEs will be graded on a 3-point scale that is mild (discomfort noticed, but no disruption of normal daily activity), moderate (discomfort sufficient to reduce or affect normal daily activity), and severe (incapacitating, with inability to work or to perform normal daily activity).

Sponsors and collaborators

Lead sponsor

Eisai GmbH

Industry

Registry information

Official study title

PERPRISE: A Prospective Non-interventional Study Evaluating the Effectiveness of Perampanel (Fycompa®) as Only Add-on Treatment in Patients With Primary or Secondarily Generalized Tonic-clonic Seizures

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2019
Registry last updated
Aug 3, 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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