{"doi":"10.1111/epi.17411","title":"Time to exceed pre‐randomization monthly seizure count for perampanel in participants with primary generalized tonic–clonic seizures: A potential clinical end point","abstract":"OBJECTIVE: To evaluate the exploratory time to exceed pre-randomization seizure count (T-PSC) in the determination of efficacy of adjunctive perampanel in participants with primary generalized tonic-clonic (PGTC) seizures in generalized-onset epilepsy. METHODS: In this multicenter, double-blind study (ClinicalTrials.gov identifier: NCT01393743), participants ≥12 years of age with treatment-resistant idiopathic generalized epilepsy were randomized to receive placebo or adjunctive perampanel (≤8 mg/day) across a 17-week double-blind treatment phase (4-week titration; 13-week maintenance). We evaluated the pre-planned exploratory end point of the T-PSC using a Kaplan-Meier analysis. We also re-evaluated the correspondence of the primary end points of median percent seizure frequency change (MPC) and 50% responder rate (50RR) calculated at T-PSC and at the end of the trial. RESULTS: The exploratory end point of median T-PSC on placebo was 43 days and >120 days on perampanel (log-rank p < .001). The primary end points calculated at T-PSC did not differ significantly from the end points at the end of the trial (MPC -31% vs -42% at T-PSC; 50RR 32% vs 51% at T-PSC). After T-PSC was reached, participants had a median (interquartile range) of 5 (3-13) additional seizures on placebo and 5 (2-10) on perampanel. SIGNIFICANCE: The exploratory end point of T-PSC demonstrated the effectiveness of perampanel despite a shorter duration of monitoring. The seizures that occurred after T-PSC did not influence the conclusions of the trial; therefore, T-PSC may be a viable alternative to traditional trial end points that reduces the risk to participants.","journal":"Epilepsia","year":2022,"id":274402,"datarank":0.37163613713265636,"base_score":2.3978952727983707,"endowment":2.3978952727983707,"self_citation_contribution":0.3596842909197557,"citation_network_contribution":0.011951846212900704,"self_endowment_contribution":0.3596842909197557,"citer_contribution":0.011951846212900704,"corpus_percentile":null,"corpus_rank":null,"citation_count":10,"citer_count":2,"citers_with_citation_signal":2,"citers_with_endowment":2,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9242,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT01393743"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":642099,"name":"Christian Brandt","orcid":"0000-0001-8666-1640","position":1,"is_corresponding":false},{"id":942890,"name":"Leock Y. Ngo","orcid":"0000-0002-8184-1367","position":2,"is_corresponding":false},{"id":719743,"name":"Anna Patten","orcid":"0000-0003-0036-9732","position":3,"is_corresponding":false},{"id":942891,"name":"Jocelyn Y. Cheng","orcid":"0000-0001-5318-5668","position":4,"is_corresponding":false},{"id":842885,"name":"Lynn D. Kramer","orcid":null,"position":5,"is_corresponding":false},{"id":262419,"name":"Jacqueline A. French","orcid":"0000-0003-2242-8027","position":6,"is_corresponding":false},{"id":368532,"name":"Wesley T. Kerr","orcid":"0000-0002-5546-5951","position":0,"is_corresponding":true}],"reference_count":26,"raw_metadata":null,"created_at":"2026-07-19T00:28:12.324621Z","pmid":"36106379","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}