Abstract Details

Title Adverse Event (AE) Profile with Perampanel as First Adjunctive Therapy in Patients with Partial-Onset Seizures: Analysis of the FAME Study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-006

Objective

To report the AE profile of perampanel as first adjunctive therapy during the FAME (Fycompa as first Add-on to Monotherapy in patients with Epilepsy) Study (Study 412, NCT02726074; conducted in Korea).

Background FAME investigated the efficacy and safety of perampanel as first adjunctive therapy in patients aged ≥12 years with partial-onset seizures, with/without secondarily generalized seizures, who had failed treatment with one previous antiepileptic drug.

Design/Methods Perampanel was up-titrated to ≤12 mg/day (12 weeks), followed by a 24-week Maintenance Period. Safety assessments (Safety Analysis Set [SAS]) included treatment-emergent AEs (TEAEs), adverse drug reactions (ADRs), serious AEs (SAEs), and TEAEs leading to discontinuation.

Results In the SAS (N=102), 77 (75.5%) patients reported 138 TEAEs and 57 (55.9%) reported 90 ADRs. Most common TEAEs were dizziness (50.0%), somnolence (9.8%), and headache (8.8%); most common ADRs were dizziness (44.1%) and somnolence (9.8%). Most TEAEs were mild (n=66 [64.7%]); one patient reported a severe TEAE (seizure). Overall, 48/138 (34.8%), 87/138 (63.0%), and 3/138 (2.2%) TEAEs were considered not related, possibly related, or probably related to perampanel, respectively. Eight (7.8%) patients had SAEs; one SAE (suicidal ideation) was possibly related to perampanel; all patients recovered. TEAEs led to discontinuation of 14 (13.7%) patients. Incidences of TEAEs, ADRs, SAEs, and TEAEs leading to discontinuation were generally higher during Titration than Maintenance or Follow-up. Overall, 29/138 (21.0%) and 1/138 (0.7%) TEAEs led to dose reduction or temporary perampanel interruption, respectively. Most patients with TEAEs recovered (113/138, 81.9%) or were in recovery (23/138, 16.7%); two patients did not recover following dizziness and diplopia.

Conclusions

These results suggest that perampanel was well tolerated with no new safety signals reported during FAME. TEAEs generally had a higher incidence during the Titration Period vs the Maintenance Period, suggesting a slower up-titration schedule may be beneficial to reduce the incidence of TEAEs.

Funding: Eisai Korea Inc.

Authors/Disclosures
Hugh Jiwoong Lee PRESENTER	Hugh Jiwoong Lee has nothing to disclose.
	No disclosure on file
	No disclosure on file
Amitabh Dash, MD	Amitabh Dash, MD has nothing to disclose.

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Abstract Details