Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6015391 | Epilepsy Research | 2015 | 5 Pages |
Abstract
Patients who received placebo in the phase III core DB studies and transitioned to perampanel in the open-label extension study (DB-PBO) achieved seizure control at the end of the conversion period similar to that of patients who had been previously exposed to perampanel (DB-PER) as well as comparable safety outcomes. Patients who received perampanel during the core studies and continued with treatment during the extension study (DB-PER) also showed sustained improvements in seizure control with long-term exposure to perampanel.
Keywords
AEDSAEFDAPBOEMAMTDEuropean Medicines agencyUS Food and Drug AdministrationITTEpilepsySimple partial seizurePartial seizurescomplex partial seizureTitrationMaximum tolerated doseantiepileptic drugperDouble blindbody mass indexBMILong-termadverse eventSerious adverse eventIntent to treatOpen-labelPerampanelPlacebo
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Authors
Georgia Montouris, Haichen Yang, Betsy Williams, Sharon Zhou, Antonio Laurenza, Randi Fain,