Efficacy and safety of two incobotulinumtoxinA injection intervals in cervical dystonia patients with inadequate benefit from standard injection intervals of botulinum toxin: Phase 4, open-label, randomized, noninferiority study.

Noninferiority of Short Flex compared with Long Flex was shown in an ANCOVA model adjusted for the baseline TWSTRS severity score (95% CI = [−2.9, 0.1] > Δ = 2.0), while there was a numerical trend toward favoring the Short Flex interval (least squares [LS] mean difference [standard error; SE], −1.4 [0.8] points; P = 0.0693) suggesting that both incobotulinumtoxinA injection intervals were effective in managing the clinical symptoms of CD.

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CDIP-58 total score was significantly improved in both the Short Flex and Long Flex groups (Short Flex mean [SE] within-treatment difference, −14.4 [2.0], P < 0.0001; Long Flex mean [SE] within-treatment difference, −12.4 [2.0], P < 0.0001) but showed a slight trend in favoring the Short Flex group (mean [SE] between-treatment change, −2.0 [2.8], P = 0.4809; Supplemental Fig. 2B).

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