Matches in SemOpenAlex for { <https://semopenalex.org/work/W2892693122> ?p ?o ?g. }
Showing items 1 to 96 of
96
with 100 items per page.
- W2892693122 endingPage "135" @default.
- W2892693122 startingPage "126" @default.
- W2892693122 abstract "Evaluate the long-term safety, tolerability, and behavioral effects of adjunctive rufinamide in pediatric patients (≥1 to <4 years old) with inadequately controlled seizures associated with Lennox-Gastaut syndrome (LGS).Study 303 (ClinicalTrials.gov identifier NCT01405053) was a multicenter, randomized, open-label, Phase III trial. Patients were randomized (2:1) to oral suspension rufinamide (≤45 mg/kg/day) or any other investigator-chosen antiepileptic drug (AED) for a 2-year treatment period. Primary safety/tolerability assessments included monitoring of treatment-emergent adverse events (TEAEs) and serious TEAEs. Behavioral effects were assessed via the Child Behavior Checklist (CBCL) using the Total Problems score and change from baseline in CBCL Total Problems score. CBCL subscores were also evaluated.The Safety Analysis Set included 37 patients (rufinamide: n = 25; any other AED: n = 12). TEAE incidence was similar between the rufinamide (88.0%) and any-other-AED groups (83.3%); serious TEAE incidence was also similar between treatment groups (40.0% and 41.7%, respectively). Between treatment groups, the difference in the least squares mean CBCL Total Problems score across time was not significant (p = 0.7083), behavior outcomes were similar across all endpoints, and there were no consistent trends in CBCL subscores.Long-term (2 years) adjunctive rufinamide was well tolerated in pediatric patients with LGS. Behavioral outcomes were comparable between the rufinamide and any-other-AED groups, however the small sample size and difficulties assessing behavior in this population should be noted. The challenges of this study raise the issue of revising how studies in very young children with rare and complex epilepsies are performed." @default.
- W2892693122 created "2018-10-05" @default.
- W2892693122 creator A5018861808 @default.
- W2892693122 creator A5030800916 @default.
- W2892693122 creator A5031104672 @default.
- W2892693122 creator A5032546678 @default.
- W2892693122 creator A5034088114 @default.
- W2892693122 creator A5038032789 @default.
- W2892693122 creator A5073487168 @default.
- W2892693122 date "2019-01-01" @default.
- W2892693122 modified "2023-09-25" @default.
- W2892693122 title "Evaluation of long-term safety, tolerability, and behavioral outcomes with adjunctive rufinamide in pediatric patients (≥1 to <4 years old) with Lennox-Gastaut syndrome: Final results from randomized study 303" @default.
- W2892693122 cites W1592759560 @default.
- W2892693122 cites W1971126719 @default.
- W2892693122 cites W1994436273 @default.
- W2892693122 cites W2039792054 @default.
- W2892693122 cites W2061457158 @default.
- W2892693122 cites W2061631774 @default.
- W2892693122 cites W2103530438 @default.
- W2892693122 cites W2137728866 @default.
- W2892693122 cites W2145377079 @default.
- W2892693122 cites W2237986469 @default.
- W2892693122 cites W2734604945 @default.
- W2892693122 cites W2760749448 @default.
- W2892693122 cites W3187413326 @default.
- W2892693122 doi "https://doi.org/10.1016/j.ejpn.2018.09.010" @default.
- W2892693122 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30309816" @default.
- W2892693122 hasPublicationYear "2019" @default.
- W2892693122 type Work @default.
- W2892693122 sameAs 2892693122 @default.
- W2892693122 citedByCount "17" @default.
- W2892693122 countsByYear W28926931222019 @default.
- W2892693122 countsByYear W28926931222020 @default.
- W2892693122 countsByYear W28926931222021 @default.
- W2892693122 countsByYear W28926931222022 @default.
- W2892693122 countsByYear W28926931222023 @default.
- W2892693122 crossrefType "journal-article" @default.
- W2892693122 hasAuthorship W2892693122A5018861808 @default.
- W2892693122 hasAuthorship W2892693122A5030800916 @default.
- W2892693122 hasAuthorship W2892693122A5031104672 @default.
- W2892693122 hasAuthorship W2892693122A5032546678 @default.
- W2892693122 hasAuthorship W2892693122A5034088114 @default.
- W2892693122 hasAuthorship W2892693122A5038032789 @default.
- W2892693122 hasAuthorship W2892693122A5073487168 @default.
- W2892693122 hasBestOaLocation W28926931221 @default.
- W2892693122 hasConcept C118552586 @default.
- W2892693122 hasConcept C126322002 @default.
- W2892693122 hasConcept C168563851 @default.
- W2892693122 hasConcept C187212893 @default.
- W2892693122 hasConcept C197934379 @default.
- W2892693122 hasConcept C2775858608 @default.
- W2892693122 hasConcept C2776749334 @default.
- W2892693122 hasConcept C2778186239 @default.
- W2892693122 hasConcept C2778375690 @default.
- W2892693122 hasConcept C2779137860 @default.
- W2892693122 hasConcept C2779307984 @default.
- W2892693122 hasConcept C2781192327 @default.
- W2892693122 hasConcept C3018162438 @default.
- W2892693122 hasConcept C71924100 @default.
- W2892693122 hasConceptScore W2892693122C118552586 @default.
- W2892693122 hasConceptScore W2892693122C126322002 @default.
- W2892693122 hasConceptScore W2892693122C168563851 @default.
- W2892693122 hasConceptScore W2892693122C187212893 @default.
- W2892693122 hasConceptScore W2892693122C197934379 @default.
- W2892693122 hasConceptScore W2892693122C2775858608 @default.
- W2892693122 hasConceptScore W2892693122C2776749334 @default.
- W2892693122 hasConceptScore W2892693122C2778186239 @default.
- W2892693122 hasConceptScore W2892693122C2778375690 @default.
- W2892693122 hasConceptScore W2892693122C2779137860 @default.
- W2892693122 hasConceptScore W2892693122C2779307984 @default.
- W2892693122 hasConceptScore W2892693122C2781192327 @default.
- W2892693122 hasConceptScore W2892693122C3018162438 @default.
- W2892693122 hasConceptScore W2892693122C71924100 @default.
- W2892693122 hasFunder F4320322148 @default.
- W2892693122 hasIssue "1" @default.
- W2892693122 hasLocation W28926931221 @default.
- W2892693122 hasLocation W28926931222 @default.
- W2892693122 hasOpenAccess W2892693122 @default.
- W2892693122 hasPrimaryLocation W28926931221 @default.
- W2892693122 hasRelatedWork W1579311408 @default.
- W2892693122 hasRelatedWork W1994380970 @default.
- W2892693122 hasRelatedWork W2046567489 @default.
- W2892693122 hasRelatedWork W2090699703 @default.
- W2892693122 hasRelatedWork W2110167505 @default.
- W2892693122 hasRelatedWork W2153016680 @default.
- W2892693122 hasRelatedWork W2892693122 @default.
- W2892693122 hasRelatedWork W3086583835 @default.
- W2892693122 hasRelatedWork W4367303782 @default.
- W2892693122 hasRelatedWork W2272393319 @default.
- W2892693122 hasVolume "23" @default.
- W2892693122 isParatext "false" @default.
- W2892693122 isRetracted "false" @default.
- W2892693122 magId "2892693122" @default.
- W2892693122 workType "article" @default.