Long-term safety of repeated high doses of incobotulinumtoxinA injections for the treatment of upper and lower limb spasticity after stroke

2017 ◽  
Vol 378 ◽  
pp. 182-186 ◽  
Author(s):  
Andrea Santamato ◽  
Francesco Panza ◽  
Domenico Intiso ◽  
Alessio Baricich ◽  
Alessandro Picelli ◽  
...  
2002 ◽  
Vol 97 (2) ◽  
pp. 315-325 ◽  
Author(s):  
Sandeep Mittal ◽  
Jean-Pierre Farmer ◽  
Borhan Al-Atassi ◽  
Joanne Gibis ◽  
Eileen Kennedy ◽  
...  

Object. Selective posterior rhizotomy (SPR) is a well-recognized treatment for children with spastic cerebral palsy (CP). Few investigators have used quantitative outcome measures to assess the surgical results beyond 3 years. The authors analyzed data obtained from the McGill Rhizotomy Database to determine the long-term functional outcome of children who had undergone selective dorsal rhizotomy accompanied by intraoperative electrophysiological monitoring. Methods. The study population was composed of children with spastic CP who underwent SPR and were evaluated by a multidisciplinary team preoperatively, and at 6 months and 1 year postoperatively. Quantitative standardized assessments of lower-limb spasticity, passive range of motion, muscle strength, and ambulatory function were obtained. Of the 93 patients who met the entry criteria for the study, 71 completed the 3-year and 50 completed the 5-year assessments, respectively. Statistical analysis demonstrated significant improvements in spasticity, range of motion, and functional muscle strength at 1 year after SPR. The preoperative, 1-, 3-, and 5-year values for the global score of the Gross Motor Function Measure were 64.6, 70.8, 80, and 85.6, respectively. The greatest improvement occurred in the dimensions reflecting lower-extremity motor function, where the mean change was 10.1% at 1 year, 19.9% at 3 years, and 34.4% at the 5-year follow-up review in comparison with the baseline value. This was associated with a lasting improvement in alignment and postural stability during developmental positions, as well as increased ability to perform difficult transitional movements. Conclusions. The results of this study support the presence of significant improvements in lower-limb functional motor outcome 1 year after SPR, and the improvements persist at 3 and 5 years. The authors conclude that SPR in conjunction with intraoperative stimulation is valuable for permanently alleviating lower-limb spasticity while augmenting motor function.


2009 ◽  
Vol 278 (1-2) ◽  
pp. 71-76 ◽  
Author(s):  
Marc Rousseaux ◽  
Nadia Buisset ◽  
Walter Daveluy ◽  
Odile Kozlowski ◽  
Serge Blond

Toxicon ◽  
2018 ◽  
Vol 156 ◽  
pp. S56
Author(s):  
Petr Kaňovský ◽  
Florian Heinen ◽  
Sebastian Schroeder ◽  
Steffen Berweck ◽  
Henry G. Chambers ◽  
...  

PM&R ◽  
2020 ◽  
Author(s):  
Alberto Esquenazi ◽  
Ganesh Bavikatte ◽  
Daniel S. Bandari ◽  
Wolfgang H. Jost ◽  
Michael C. Munin ◽  
...  

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Theodore Wein ◽  
Alberto Esquenazi ◽  
Wolfgang H Jost ◽  
Anthony Ward ◽  
Tinna Kwan ◽  
...  

Introduction: Long-term efficacy of onabotulinumtoxinA (onabotA) in post-stroke lower limb spasticity (PSLLS) is not clearly established. Hypothesis: OnabotA provides sustained efficacy in PSLLS. Methods: A multicenter, phase 3, 12-week, double-blind (DB), placebo-controlled study of patients with ankle PSLLS (Modified Ashworth Scale [MAS] ≥3) was followed by an open-label (OL) extension, during which all patients received 1-3 treatment cycles (∼12-week intervals) of onabotA (≤400U). Endpoints: change from baseline in MAS and Clinical Global Impression of Change (CGI) physician rating, and percent of patients achieving passive and active goals (Goal Attainment Scale [GAS]) by physician and patient. Results: 468 patients enrolled (onabotA, n=233; placebo, n=235); 447 (95.5%) completed the DB and 249 (53.2%) completed the OL phase at DB database lock. Significant improvement in MAS achieved with onabotA in DB was sustained in OL phase (Table). Significant improvements in CGI in DB continued to improve in OL phase. During OL phase, MAS ankle change from baseline and CGI by physician raw scores and proportions of responders were largest at week 6 and generally increased over 3 OL treatment cycles. With onabotA, GAS by patient improved ( P =0.036), as did the proportion that progressed toward active ( P =0.009) and passive ( P =0.044) goal attainment by physician. The percentage of patients who met passive and active goals (GAS by physician≥0) after 1 onabotA treatment increased from 40% to 64% and 27% to 65%, respectively, after 4 treatments. Common DB treatment-related AEs (onabotA vs placebo): injection-site pain (1.7% vs 0.9%) and pain in extremity (0.4% vs 2.1%). Conclusions: OnabotA was well-tolerated and produced improvements in MAS, CGI, and GAS during the DB phase that continued into the OL phase, demonstrating long-term benefits in patients with PSLLS.


PM&R ◽  
2018 ◽  
Vol 10 ◽  
pp. S31-S31
Author(s):  
Alberto Esquenazi ◽  
Wolfgang H. Jost ◽  
Ganesh Bavikatte ◽  
Daniel S. Bandari ◽  
Michael C. Munin ◽  
...  

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