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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

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ClinicalTrials.gov Identifier: NCT04252846
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

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.

Condition or disease Intervention/treatment
Idiopathic Generalized Epilepsy Partial Onset Seizures Generalised Tonic-Clonic Seizures Drug: Perampanel

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Perampanel

Group/Cohort Intervention/treatment
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
Perampanel oral tablets or oral suspension.
Other Name: Fycompa




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 300 participants with diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE)
Criteria

Inclusion Criteria:

  1. Diagnosis of epilepsy
  2. History of POS with or without SG or PGTCS associated with IGE
  3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
  4. Previously treated with 1 or 2 AEDs as monotherapy
  5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency

Exclusion Criteria:

  1. Episode(s) of status epilepticus within the past 6 months before Screening
  2. Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)
  3. 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

  4. Hypersensitivity to perampanel or any of the excipients

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): NCT04252846


Contacts
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Contact: Eisai Medical Information EUMedInfo@eisai.net

Locations
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Sponsors and Collaborators
Eisai Limited
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Responsible Party: Eisai Limited
ClinicalTrials.gov Identifier: NCT04252846    
Other Study ID Numbers: E2007-M044-512
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc. ( Eisai Limited ):
Perampanel
Fycompa
Epilepsy
Seizures
Prospective
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms