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OpenTrials
Completed

NCT Number: NCT02736162

Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy

The primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Partial-onset Seizures Primary Generalized Tonic-clonic Seizures

Sex eligibility

All sexes

Study type

Observational

About this study

This study is a retrospective study of participants who received perampanel as primary or secondary monotherapy at approximately 40 centers in Europe, Asia, and Australia. Primary monotherapy is defined as the administration of perampanel in the absence of any concomitant antiepileptic drugs (AEDs). Secondary (conversion) monotherapy is defined as the conversion of perampanel from adjunctive therapy to monotherapy by withdrawing concomitant AEDs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of epilepsy
  • Received perampanel as primary or secondary monotherapy at any time between 1 Jan 2013 and 15 Oct 2015
  • Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records per local requirements

Exclusion criteria

  • Not applicable

Treatment and study plan

No treatment (intervention) was administered

Other

Primary outcomes

  1. Retention rate

    Time frame: Month 3

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

  2. Retention rate

    Time frame: Month 6

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

  3. Retention rate

    Time frame: Month 12

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

  4. Retention rate

    Time frame: Month 18

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

  5. Retention rate

    Time frame: Month 24

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

  6. Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)

    Time frame: Up to approximately 34 months

Secondary outcomes

  1. Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel

    Time frame: Up to approximately 34 months

  2. Percentage of participants with greater than or equal to 50% reduction in seizure frequency

    Time frame: Up to approximately 34 months

  3. Percentage of participants who were seizure-free for at least 3 months

    Time frame: Up to approximately 34 months

    Seizure-free is defined as a terminal remission of seizures

  4. Percentage of participants with greater than or equal to 75% reduction in seizure frequency

    Time frame: Up to approximately 34 months

  5. Percentage of participants with categorized percent reductions in seizure frequency

    Time frame: Up to approximately 34 months

  6. Percentage of participants with no change or worsening of seizures

    Time frame: Up to approximately 34 months

  7. Median percent change in seizure frequency

    Time frame: Up to approximately 34 months

  8. Percentage of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)

    Time frame: Up to approximately 34 months

  9. Mean change in body weight

    Time frame: Up to approximately 34 months

  10. Maximum dose of perampanel during adjunctive therapy and monotherapy

    Time frame: Up to approximately 34 months

  11. Average dose of perampanel during adjunctive therapy and monotherapy

    Time frame: Up to approximately 34 months

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 13, 2016
Registry last updated
Mar 9, 2017

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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