Eisai begins two Phase III clinical studies of perampanel in children with inadequately controlled partial-onset (focal) seizures or primary generalised tonic-clonic (PGTC) seizures and Lennox-Gastaut Syndrome related seizures.
The global multicentre, open-label, single-arm Study 311 with an extension phase intends to test the safety, tolerability and exposure-efficacy relationship of perampanel oral suspension.
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The study involves children ages four to 11 with inadequately controlled partial-onset seizures or primary generalised tonic-clonic seizures and will be treated for a period of 23 weeks.
The study's extension phase will evaluate the long-term safety of perampanel.
The global double-blind, randomised, placebo-controlled study 338 with an open-label extension intends to test the efficacy and safety of adjunctive perampanel in examining 140 subjects aged two and older with seizures associated with Lennox-Gastaut Syndrome.
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Patients will receive oral administration of perampanel on a once-daily basis and placebo.
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By GlobalDataThe study is primarily focused on achieving a median percentage change in drop seizure frequency after an interval of 28 days during double-blind treatment of 18 weeks.
Eisai neurology business group chief clinical officer and chief medical officer Dr Lynn Kramer said: "We are committed to helping children with epilepsy manage their condition through the continued development of treatment options such as perampanel.
“Through the initiation of these two clinical trials we hope to improve our understanding of perampanel in children with epilepsy.”
Perampanel has been developed as a highly selective, non-competitive AMPA alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)-type glutamate receptor antagonist.
AMPA receptors populates almost all excitatory neurons and transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are considered to be responsible for central nervous system diseases characterised by excess neuroexcitatory signalling, including epilepsy.
