Matches in SemOpenAlex for { <https://semopenalex.org/work/W2562731026> ?p ?o ?g. }
Showing items 1 to 94 of
94
with 100 items per page.
- W2562731026 abstract "Objective: To assess long term safety and efficacy of abobotulinumtoxinA in hemiparetic patients with upper limb spasticity (ULS) post stroke/traumatic brain injury (TBI) over repeated treatment cycles. Background: Few studies have assessed long term safety and efficacy of repeated botulinum toxin injections in the treatment of adult spasticity. Methods: Phase III, multicentre, open-label extension including patients from a double-blind (DB) study (published) and de novo patients. Patients (18-78 years) received abobotulinumtoxinA 500U, 1000U or 1500U (per investigator’s judgement) for up to 4/5 cycles. Safety (primary objective) assessments consisted of monitoring treatment emergent adverse events (TEAEs), vital signs, laboratory and ECG. Efficacy assessments included muscle tone (Modified Ashworth Scale, MAS) in the primary targeted muscle group (PTMG), Physician Global Assessment (PGA) and Disability Assessment Scale (DAS) in the principal target of treatment (PTT) (primary/secondary endpoints in DB). Results for abobotulinumtoxinA, irrespective of dose administered (i.e. 500U/1000U/1500U combined), over cycles are presented. Results: Safety population comprised 258 patients (31 de novo). Incidence of TEAEs decreased with each cycle (41.6[percnt] [DB] to 13.6[percnt] [cycle 4, C4]). No clinically significant changes in haematology/biochemistry, vital signs and ECG occurred over cycles. Safety was comparable between doses. The percentage of MAS responders (≥1 grade reduction from baseline to Week 4) in PTMG was maintained at 75[percnt] from DB to C4. Mean (SD) PGA at Week 4 improved from 1.5 (1.0) in DB to 2.0 (0.9) at C4. The percentage of responders (≥1 grade reduction from baseline to Week 4) in DAS for the PTT also improved over cycles (55[percnt] [DB] to 74[percnt] [C4]). Conclusions: Safety analysis in this long term study did not generate any new unexpected safety findings; safety profile was similar across doses. Repeated abobotulinumtoxinA injections were associated with sustained or progressive improvement in muscle tone, perceived function (DAS) and global assessment in ULS patients post stroke/TBI.Supported by:Ipsen Disclosure: Dr. Brashear has received personal compensation for activities with Allergan, Ipsen, Revance and Concerta as a consultant. Dr. Brashear has received royalty payments from books royalties. Dr. Brashear has received research support from Ipsen, Merz, Allerg Dr. Marciniak has nothing to disclose. Dr. Edgley has received research support from Ipsen. Dr. Gul has received research support from FG as an investigator in an Ipsen trial. Dr. Hedera has nothing to disclose. Dr. McAllister has received personal compensation for activities with Teva CNS, Allergan, Mallinckrodt, Ipsen, Merz Pharmaceuticals, Depomed, Pfizer and XenoPort as a speaker. Dr. O9Dell has received research support from Ipsen. Dr. Rubin has received personal compensation for activities with Allergan and Merz as a speaker. Dr. Walker has received research support from Ipsen. Dr. Vilain has received personal compensation for activities with Ipsen Innovation as an employee. Dr. Mahmood has received personal compensation for activities with Ipsen as an employee. Dr. Gracies has received research support from Ipsen." @default.
- W2562731026 created "2017-01-06" @default.
- W2562731026 creator A5015268338 @default.
- W2562731026 creator A5028242243 @default.
- W2562731026 creator A5040426879 @default.
- W2562731026 creator A5040730411 @default.
- W2562731026 creator A5045728494 @default.
- W2562731026 creator A5053109281 @default.
- W2562731026 creator A5054926303 @default.
- W2562731026 creator A5058587563 @default.
- W2562731026 creator A5067469413 @default.
- W2562731026 creator A5070982600 @default.
- W2562731026 creator A5086581370 @default.
- W2562731026 creator A5089025359 @default.
- W2562731026 date "2016-04-05" @default.
- W2562731026 modified "2023-10-18" @default.
- W2562731026 title "Extension Study to Assess the Safety and Efficacy of Repeated AbobotulinumtoxinA Injections in Adults with Upper Limb Spasticity (P3.307)" @default.
- W2562731026 hasPublicationYear "2016" @default.
- W2562731026 type Work @default.
- W2562731026 sameAs 2562731026 @default.
- W2562731026 citedByCount "0" @default.
- W2562731026 crossrefType "journal-article" @default.
- W2562731026 hasAuthorship W2562731026A5015268338 @default.
- W2562731026 hasAuthorship W2562731026A5028242243 @default.
- W2562731026 hasAuthorship W2562731026A5040426879 @default.
- W2562731026 hasAuthorship W2562731026A5040730411 @default.
- W2562731026 hasAuthorship W2562731026A5045728494 @default.
- W2562731026 hasAuthorship W2562731026A5053109281 @default.
- W2562731026 hasAuthorship W2562731026A5054926303 @default.
- W2562731026 hasAuthorship W2562731026A5058587563 @default.
- W2562731026 hasAuthorship W2562731026A5067469413 @default.
- W2562731026 hasAuthorship W2562731026A5070982600 @default.
- W2562731026 hasAuthorship W2562731026A5086581370 @default.
- W2562731026 hasAuthorship W2562731026A5089025359 @default.
- W2562731026 hasConcept C120665830 @default.
- W2562731026 hasConcept C121332964 @default.
- W2562731026 hasConcept C126322002 @default.
- W2562731026 hasConcept C127413603 @default.
- W2562731026 hasConcept C1862650 @default.
- W2562731026 hasConcept C197934379 @default.
- W2562731026 hasConcept C203092338 @default.
- W2562731026 hasConcept C2777478456 @default.
- W2562731026 hasConcept C2779012798 @default.
- W2562731026 hasConcept C2780645631 @default.
- W2562731026 hasConcept C2908647359 @default.
- W2562731026 hasConcept C42219234 @default.
- W2562731026 hasConcept C535046627 @default.
- W2562731026 hasConcept C61511704 @default.
- W2562731026 hasConcept C71924100 @default.
- W2562731026 hasConcept C78519656 @default.
- W2562731026 hasConcept C99454951 @default.
- W2562731026 hasConceptScore W2562731026C120665830 @default.
- W2562731026 hasConceptScore W2562731026C121332964 @default.
- W2562731026 hasConceptScore W2562731026C126322002 @default.
- W2562731026 hasConceptScore W2562731026C127413603 @default.
- W2562731026 hasConceptScore W2562731026C1862650 @default.
- W2562731026 hasConceptScore W2562731026C197934379 @default.
- W2562731026 hasConceptScore W2562731026C203092338 @default.
- W2562731026 hasConceptScore W2562731026C2777478456 @default.
- W2562731026 hasConceptScore W2562731026C2779012798 @default.
- W2562731026 hasConceptScore W2562731026C2780645631 @default.
- W2562731026 hasConceptScore W2562731026C2908647359 @default.
- W2562731026 hasConceptScore W2562731026C42219234 @default.
- W2562731026 hasConceptScore W2562731026C535046627 @default.
- W2562731026 hasConceptScore W2562731026C61511704 @default.
- W2562731026 hasConceptScore W2562731026C71924100 @default.
- W2562731026 hasConceptScore W2562731026C78519656 @default.
- W2562731026 hasConceptScore W2562731026C99454951 @default.
- W2562731026 hasOpenAccess W2562731026 @default.
- W2562731026 hasRelatedWork W1042487492 @default.
- W2562731026 hasRelatedWork W14941675 @default.
- W2562731026 hasRelatedWork W1555860353 @default.
- W2562731026 hasRelatedWork W1574617653 @default.
- W2562731026 hasRelatedWork W1657838061 @default.
- W2562731026 hasRelatedWork W2027348910 @default.
- W2562731026 hasRelatedWork W2047565140 @default.
- W2562731026 hasRelatedWork W2461310150 @default.
- W2562731026 hasRelatedWork W2472696471 @default.
- W2562731026 hasRelatedWork W2770501766 @default.
- W2562731026 hasRelatedWork W2794555652 @default.
- W2562731026 hasRelatedWork W2795807623 @default.
- W2562731026 hasRelatedWork W2806417025 @default.
- W2562731026 hasRelatedWork W2808114370 @default.
- W2562731026 hasRelatedWork W2809523820 @default.
- W2562731026 hasRelatedWork W2890443921 @default.
- W2562731026 hasRelatedWork W2898365980 @default.
- W2562731026 hasRelatedWork W2901176018 @default.
- W2562731026 hasRelatedWork W2976572331 @default.
- W2562731026 hasRelatedWork W3100352795 @default.
- W2562731026 hasVolume "86" @default.
- W2562731026 isParatext "false" @default.
- W2562731026 isRetracted "false" @default.
- W2562731026 magId "2562731026" @default.
- W2562731026 workType "article" @default.