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

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ClinicalTrials.gov Identifier: NCT02736162
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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

Condition or disease Intervention/treatment
Epilepsy Partial-Onset Seizures Primary Generalized Tonic-Clonic Seizures Other: No treatment (intervention) was administered

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Perampanel

Group/Cohort Intervention/treatment
Perampanel
Participants with a diagnosis of epilepsy who received perampanel as primary or secondary (conversion) monotherapy at any time between 1 Jan 2013 and 15 Oct 2015.
Other: No treatment (intervention) was administered



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who received perampanel as primary or secondary monotherapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736162


Sponsors and Collaborators
Eisai Inc.
Investigators
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Study Director: Karen Cartwright, PhD Eisai Limited

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02736162     History of Changes
Other Study ID Numbers: E2007-G000-504
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Eisai Inc.:
Perampanel
E2007
Phase 4
Fycompa
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms