biostudies-literatureUnknown97(18)French JA<h4>Background and objectives</h4>To explore efficacy/safety of natalizumab, a humanized monoclonal anti-α4-integrin antibody, as adjunctive therapy in adults with drug-resistant focal epilepsy.<h4>Methods</h4>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.<h4>Results</h4>Of 32 and 34 participants doseNeurologye1757-e1767https://www.ebi.ac.uk/biostudies/studies/S-EPMC8610627biostudies-literatureSafety and Efficacy of Natalizumab as Adjunctive Therapy for People With Drug-Resistant Epilepsy: A Phase 2 Study.PMC8610627Tecoma ERafecas JGelfand MAyala RVezzani AFaught EVossler DBeach RShin HKassab MTing THusain AHoneycutt WBautista RSarkis ROPUS Study GroupLiow KHalford JJBenbadis SOster JPatel JFlitman SBerg MKnafler GChen KTheodore WHKlein PBalabanov AHubbard SSirven JCole AJSzaflarski JPHogan EHarvey JFrench JAKudrow DElkins JParkerson KAFeng WRizzo MBoro AArmstrong RKoubeissi MLee KHCarran MfalseSafety and Efficacy of Natalizumab as Adjunctive Therapy for People With Drug-Resistant Epilepsy: A Phase 2 Study.<h4>Background and objectives</h4>To explore efficacy/safety of natalizumab, a humanized monoclonal anti-α4-integrin antibody, as adjunctive therapy in adults with drug-resistant focal epilepsy.<h4>Methods</h4>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.<h4>Results</h4>Of 32 and 34 participants dose2021-01-01T00:00:00Z2021 Nov2025-04-05T14:54:40.742Z2025-04-05T14:54:40.742ZS-EPMC86106273452168710.1212/wnl.000000000001276610.1212/WNL.0000000000012766