A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures
NCT ID: NCT04202159
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
187 participants
OBSERVATIONAL
2020-01-21
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Perampanel
Participants with PGTC or SGTC seizures may receive perampanel tablets or oral suspension as only add-on therapy based on physicians decision in accordance with summary of product characteristics (SmPC) and will be observed at baseline, 6 months (intermediate visit), and 12 months (final visit).
Perampanel
Perampanel tablets.
Perampanel
Perampanel oral suspension.
Interventions
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Perampanel
Perampanel tablets.
Perampanel
Perampanel oral suspension.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Active epilepsy with GTC seizures, demonstrated by the occurrence of at least 1 GTC seizure within 3 months before inclusion
3. The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study
4. Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC
5. 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
2. The participant had already received perampanel in the past
3. Simultaneous participation in an interventional clinical study and/or taking an investigational drug
18 Years
ALL
No
Sponsors
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Eisai GmbH
INDUSTRY
Responsible Party
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Locations
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Eisai Trial Site #51
Aalen, , Germany
Eisai Trial Site #12
Berlin, , Germany
Eisai Trial Site #43
Berlin, , Germany
Eisai Trial Site #15
Bernau, , Germany
Eisai Trial Site #8
Bielefeld, , Germany
Eisai Trial Site #53
Bochum, , Germany
Eisai Trial Site #38
Bonn, , Germany
Eisai Trial Site #9
Bonn, , Germany
Eisai Trial Site #25
Damp, , Germany
Eisai Trial Site #48
Dortmund, , Germany
Eisai Trial Site #27
Dresden, , Germany
Eisai Trial Site #50
Dresden, , Germany
Eisai Trial Site #7
Erlangen, , Germany
Eisai Trial Site #44
Friedrichshafen, , Germany
Eisai Trial Site #4
Greifswald, , Germany
Eisai Trial Site #21
Hamburg, , Germany
Eisai Trial Site #47
Hamburg, , Germany
Eisai Trial Site #14
Jena, , Germany
Eisai Trial Site #18
Kiel, , Germany
Eisai Trial Site #54
Kiel, , Germany
Eisai Trial Site #1
Kork, , Germany
Eisai Trial Site #24
Leipzig, , Germany
Eisai Trial Site #28
Lübeck, , Germany
Eisai Trial Site #26
Magdeburg, , Germany
Eisai Trial Site #13
Mainz, , Germany
Eisai Trial Site #36
Mittweida, , Germany
Eisai Trial Site #42
Nierstein, , Germany
Eisai Trial Site #2
Radeberg, , Germany
Eisai Trial Site #16
Ravensburg, , Germany
Eisai Trial Site #23
Regensburg, , Germany
Eisai Trial Site #46
Remscheid, , Germany
Eisai Trial Site #3
Tübingen, , Germany
Eisai Trial Site #37
Ulm, , Germany
Eisai Trial Site #40
Weil der Stadt, , Germany
Countries
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Other Identifiers
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E2007-M049-509
Identifier Type: -
Identifier Source: org_study_id
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