Eisai has announced the initiation of two multicenter, global phase III clinical trials assessing FYCOMPA (perampanel) CIII in two different patient populations: patients age 2 years and above with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS) (Study 338), a rare and often debilitating form of childhood-onset epilepsy, and in children ages 4 through 11 years with inadequately controlled partial-onset seizures (POS) (Study 311).
FYCOMPA is indicated as an adjunctive therapy for the treatment of POS with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy who are 12 years of age and older. FYCOMPA is not indicated for LGS, or for patients younger than 12.
"We are committed to helping the epilepsy community through the continued development of options that may address unmet medical needs," said Lynn Kramer, M.D., chief clinical officer and chief medical officer, Neurology Business Group, Eisai. "Through the initiation of these two clinical trials one that looks at the pediatric population and the other involving those with LGS we hope to demonstrate the value of perampanel for a broader range of patients who suffer from these conditions."
Study 311 is the first pivotal study to follow the November 2015 FDA communication to sponsors that allowed companies "to extrapolate to pediatric patients 4 years of age and older the effectiveness of drugs approved for the treatment of partial-onset seizures (POS) in adults." Under this policy, drug manufacturers must also provide long-term, open-label safety data in patients 4 years and older, the data that Study 311 is designed to provide.
This release discusses investigational uses for an FDA-approved product. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain FDA approval.
About Study 338 (Evaluating perampanel in Patients with LGS)
The primary objective of Study 338, a double-blind, randomized, placebo-controlled trial with an open-label extension, will be to evaluate whether perampanel, when given as adjunctive antiepileptic treatment, is superior to placebo in reducing the number of drop seizures in participants at least 2 years of age with inadequately controlled seizures associated with LGS. Key secondary objectives include evaluating whether perampanel given as adjunctive antiepileptic treatment is superior to placebo in reducing the incidence of all seizures in study subjects; and evaluating whether perampanel given as adjunctive antiepileptic treatment is superior to placebo in the 50% responder rate for drop seizures, non-drop and total seizures, respectively, in study subjects.
The study will enroll approximately 142 patients receiving 1-3 concomitant antiepileptic drugs (AEDs). Study participants will be randomized to receive perampanel up to 8mg or placebo in a 1:1 ratio during three periods: titration (6 weeks), maintenance (12 weeks), and follow-up (four weeks).
About Study 311 (Evaluating perampanel in Children ages 4 through 11)
Study 311 is a global open-label, multicenter trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of perampanel oral suspension when administered as an adjunctive therapy in children, ages 4 through 11, with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures. Study 311 will enroll roughly 160 patients—approximately 120 with partial-onset seizures and 40 with primary generalized tonic-clonic seizures, who will undergo pretreatment and treatment phases, during which they will be administered up to 12 mg of perampanel daily. The primary endpoint will be safety and tolerability, which include incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), laboratory parameters, vital signs, and ECG parameters.
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, which affects 2.9 million people in the U.S. Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60% of all seizures. Generalized seizures account for approximately 40% of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of generalized seizures. Lennox-Gastaut Syndrome is diagnosed in more than 30,000 children and adults in the U.S.