Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized‐controlled trial

Abstract

Although the predefined noninferiority criterion was not met, abobotulinumtoxinA solution for injection was similarly effective to freeze-dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale total scores with a similar safety profile. AbobotulinumtoxinA solution for injection efficacy was maintained with chronic open-label treatment, and this novel formulation may add convenience as well as dosing accuracy to treatment with abobotulinumtoxinA. © 2016 International Parkinson and Movement Disorder Society.

Quality of life improvements in patients with cervical dystonia following treatment with a liquid formulation of abobotulinumtoxinA (Dysport®)

“…Of the 369 patients randomized in cycle 1, 156 received ASI, 159 received abobotulinumtoxinA and 54 received placebo . In general, patients had relatively severe symptoms at baseline (TWSTRS total score of 45.6 ± 9.1) and the mean CDIP‐58 total score of 59.1 ± 14.4 confirmed the negative impact of CD on patient QoL (Table S2).…”

“…: +33561779474; fax: +33561777304; e-mail: simonetta.m@chu-toulouse.fr). with repeat treatment [1]. Here, quality of life (QoL) data collected as a secondary measure using the disease-specific Cervical Dystonia Impact Profile (CDIP-58) are presented [2].…”

Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose‐Escalation Multicenter Study

“…For example, a mean reduction in TWSTRS‐Total score of 9.9 has been reported for incobotulinumtoxinA 120 U,12 10.9 for incobotulinumtoxinA 240 U,12 9.3 for botulinum toxin type B 5,000 U,13 11.7 for botulinum toxin type B 10,000 U,13 9.9 for abobotulinumtoxinA 500 U,14 and a least squares mean reduction of approximately 14 for abobotulinumtoxinA 500 U 15. However, these previous studies were larger, double blind, and placebo controlled, so these differences may not be meaningful.…”

Placebo and nocebo responses in other movement disorders besides Parkinson's disease: How much do we know?

“…35,36 A placebo administration was associated with a slight improvement in the Cervical Dystonia Severity Scale (-0.31 points) and Physician Global Assessment Scale (41.6%) at week 6 compared with baseline. 37 A placebo response was also observed in the total score of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) with a 3.8-to 3.9-point reduction at week 4 38,39 and induced-treatment responder rates between 10% and 16%. [38][39][40] Using the pain subscale of the TWSTRS, there was a placebo-associated response rate of 19% to 23% and mean improvement of 0.1 to 0.5.…”

“…37 A placebo response was also observed in the total score of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) with a 3.8-to 3.9-point reduction at week 4 38,39 and induced-treatment responder rates between 10% and 16%. [38][39][40] Using the pain subscale of the TWSTRS, there was a placebo-associated response rate of 19% to 23% and mean improvement of 0.1 to 0.5. 41 In a sham-controlled trial for medication-refractory cervical dystonia, patients were randomly assigned to receive active pallidal neurostimulation or sham neurostimulation (amplitude = 0 V).…”