Vineet Punia, MD, MS: Initial Data from ELEVATE Trial of Perampanel for Focal Onset Seizures

“The elevate study being the first of its kind where we are trying it as a monotherapy, or first adjunctive therapy, gives us a lot of hope that we will have new, very useful data in the future once the study is complete and analysis is done. The hope is that we find it to be safe and effective in terms of helping with seizure control.”

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; POS seizures are now officially referred to as focal-onset 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 all of these seizure types. 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 about perampanel and the results of the trial to this point.

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.