Vineet Punia, MD, MS: Phase 4 ELEVATE Trial of Perampanel for Partial Onset Seizures

“Perampanel is a first of its class drug that has a very unique mechanism of action. It is a selective, non-competitive antagonist at the very center of the blood glutamate neurotransmitter system. So, it is a very unique mechanism of action. And based on that there is a lot of potential in its effect in controlling seizures in patients both who have focal onset epilepsy or generalized onset epilepsy.”

Data from the phase 4 ELEVATE study (Study 410; NCT03288129) presented at the American Epilepsy Society (AES) Annual Meeting, December 4–8, 2020, demonstrated that overall, patients with partial-onset seizures (POS) or primary generalized tonic-clonic seizures (PGTCS) were compliant with perampanel (Fycompa; Eisai) treatment and that the therapy was well tolerated.

The ongoing 12-month, multicenter, open-label, phase 4 study is the first prospective study of perampanel administered as monotherapy or first adjunctive therapy in patients aged ≥4 years with POS, with or without secondary generalized (SGS) or PGTCS. (editor’s note: PGTCS seizures are now officially referred to as genetic generalized tonic-clonic seizures.)

The data, presented by Vineet Punia, MD, MS, neurologist, Cleveland Clinic, showed that patients were compliant with using perampanel as monotherapy or as the first adjunctive treatment for POS, SGS, or PGTCS. Ultimately, the study findings showed that compliance rates of >90%, 80% to <90%, and 70% to <80% were reported by 69.2% (n= 9), 7.7% (n = 1) and 23.1% (n = 3) of the 13-patient cohorts, respectively. NeurologyLive talked to Punia in this interview to learn more perampanel and the trial. 

To view NeurologyLive’s previous coverage of the ELEVATE trial, click here.

For more coverage of AES 2020, click here.

REFERENCE
Punia V, Klein P, Kumar D, Salah A, Malhotra M. ELEVATE study 410 initial results: Phase IV study of perampanel as monotherapy or first adjunctive therapy in patients aged ≥4 years with partial-onset or primary generalized tonic-clonic seizures. Presented at AES 2020 Annual Meeting; December 4–8, 2020. Abstract 766.