Perampanel: Phase III data

In the double-blind, dose-escalation, international Phase III Study 306 trial in 706 patients, 4 and 8 mg doses of perampanel as an adjunctive therapy met the primary endpoint of significantly reducing median seizure frequency per 28 days in the maintenance period vs. placebo. The 2 mg dose missed the endpoint. Mid- and high-dose perampanel also met the secondary endpoint of significantly increasing responder rates, defined as a >=50% reduction in seizure frequency during the maintenance period, vs. placebo, but low-dose perampanel missed the endpoint.

Perampanel was well tolerated with dizziness, somnolence and headache reported as the most common adverse events. Patients initially received 2 mg perampanel, then either remained on 2 mg or had their dosage increased weekly in 2 mg increments to 4 or 8 mg perampanel. The 6-week titration phase was followed by a 13-week maintenance period. ...