{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["97(18)"],"submitter":["French JA"],"pubmed_abstract":["Background and objectives
To explore efficacy/safety of natalizumab, a humanized monoclonal anti-α4-integrin antibody, as adjunctive therapy in adults with drug-resistant focal epilepsy.Methods
Participants with ≥6 seizures during the 6-week baseline period were randomized 1:1 to receive natalizumab 300 mg IV or placebo every 4 weeks for 24 weeks. Primary efficacy outcome was change from baseline in log-transformed seizure frequency, with a predefined threshold for therapeutic success of 31% relative reduction in seizure frequency over the placebo group. Countable seizure types were focal aware with motor signs, focal impaired awareness, and focal to bilateral tonic-clonic. Secondary efficacy endpoints/safety were also assessed.Results
Of 32 and 34 participants dose"],"journal":["Neurology"],"pagination":["e1757-e1767"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8610627"],"repository":["biostudies-literature"],"pubmed_title":["Safety and Efficacy of Natalizumab as Adjunctive Therapy for People With Drug-Resistant Epilepsy: A Phase 2 Study."],"pmcid":["PMC8610627"],"pubmed_authors":["Tecoma E","Rafecas J","Gelfand M","Ayala R","Vezzani A","Faught E","Vossler D","Beach R","Shin H","Kassab M","Ting T","Husain A","Honeycutt W","Bautista R","Sarkis R","OPUS Study Group","Liow K","Halford JJ","Benbadis S","Oster J","Patel J","Flitman S","Berg M","Knafler G","Chen K","Theodore WH","Klein P","Balabanov A","Hubbard S","Sirven J","Cole AJ","Szaflarski JP","Hogan E","Harvey J","French JA","Kudrow D","Elkins J","Parkerson KA","Feng W","Rizzo M","Boro A","Armstrong R","Koubeissi M","Lee KH","Carran M"],"additional_accession":[]},"is_claimable":false,"name":"Safety and Efficacy of Natalizumab as Adjunctive Therapy for People With Drug-Resistant Epilepsy: A Phase 2 Study.","description":"Background and objectives
To explore efficacy/safety of natalizumab, a humanized monoclonal anti-α4-integrin antibody, as adjunctive therapy in adults with drug-resistant focal epilepsy.Methods
Participants with ≥6 seizures during the 6-week baseline period were randomized 1:1 to receive natalizumab 300 mg IV or placebo every 4 weeks for 24 weeks. Primary efficacy outcome was change from baseline in log-transformed seizure frequency, with a predefined threshold for therapeutic success of 31% relative reduction in seizure frequency over the placebo group. Countable seizure types were focal aware with motor signs, focal impaired awareness, and focal to bilateral tonic-clonic. Secondary efficacy endpoints/safety were also assessed.Results
Of 32 and 34 participants dose","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Nov","modification":"2025-04-05T14:54:40.742Z","creation":"2025-04-05T14:54:40.742Z"},"accession":"S-EPMC8610627","cross_references":{"pubmed":["34521687"],"doi":["10.1212/wnl.0000000000012766","10.1212/WNL.0000000000012766"]}}