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Abstract Details

Perampanel Monotherapy Beyond Initial Titration to Achieve Seizure Freedom in Patients With Partial-Onset Seizures (POS), With/Without Secondarily Generalized Seizures (SGS): Post Hoc Analysis of Phase III Study 342 (FREEDOM)
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
008
To evaluate if continued treatment with perampanel monotherapy, beyond initial titration, may be required to achieve seizure freedom with an effective maintenance dose.
The FREEDOM Study (NCT03201900) evaluated perampanel monotherapy in patients aged 12–74 years with newly diagnosed/currently untreated recurrent POS, with/without SGS, in Japan/South Korea. The Treatment Phase comprised a 6-week Titration Period (2 mg/day [2 weeks], 4 mg/day [4 weeks]) and 26-week Maintenance Period (4 mg/day; or, in case of seizures, up to 8 mg/day). During the Maintenance Period, seizure freedom was achieved by 46/73 (63.0%) patients receiving 4 mg/day (Yamamoto T et al. Epilepsia Open 2020;5:274-284).
In this post hoc analysis, seizure frequency data from the modified intent-to-treat (mITT) population (patients with ≥1 post-dose efficacy assessment during the 4-mg/day Maintenance Period) were analyzed to determine whether patients who achieved seizure freedom over the 26-week 4-mg/day Maintenance Period (4-mg responders) experienced an early response during the Titration Period (early-responders; defined as no seizures during Titration).
Of 73 patients in the mITT population, 46 patients achieved seizure freedom over the 26-week Maintenance Period with perampanel 4 mg/day (4-mg responders): 37/46 (80.4%) of these had early responses during Titration (early-responders), while 9/46 (19.6%) were not early-responders but went onto achieve seizure freedom during Maintenance. The remaining 27 patients did not achieve seizure freedom over the 26-week 4-mg/day Maintenance Period (4-mg non-responders): 18/27 (66.7%) of these had seizures during Titration, while 9/27 (33.3%) had early responses but did not achieve seizure freedom for 26 weeks during Maintenance with perampanel 4 mg/day.

Whilst the majority of patients with an early response during Titration continued to be seizure free during Maintenance, some patients without an early response during Titration could still achieve seizure freedom upon continued maintenance treatment with perampanel 4 mg/day.

Funding: Eisai Co., Ltd.
Authors/Disclosures
Ryan Edbert Husni
PRESENTER 		Ryan Edbert Husni has received personal compensation for serving as an employee of Eisai, Co. Ltd. Ryan Edbert Husni has received personal compensation in the range of $500-$4,999 for serving as a Foreign Scholar with Japan Ministry of Â鶹´«Ã½Ó³»­, Culture, Sports, Science and Technology (MEXT).
Stella L. Ngo, PhD Dr. Ngo has received personal compensation for serving as an employee of Neurelis Inc.. Dr. Ngo has received personal compensation for serving as an employee of Neurelis Inc..
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Takamichi Yamamoto, MD, PhD, FAES (Seirei Mikatahara General Hospital) Dr. Yamamoto has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. Dr. Yamamoto has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Daiichi-Sankyo.