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- W2806417025 abstract "Objective: To examine the safety and efficacy of incobotulinumtoxinA for treating sialorrhea due to PD and other etiologies. Background: Sialorrhea is troublesome and disabling symptom often associated with various neurological conditions. Design/Methods: The study enrolled adults with chronic, troublesome sialorrhea due to neurological etiologies (eg, PD, stroke). Subjects were randomized to 3 groups: 75U or 100U incobotulinumtoxinA, or placebo. For the higher/lower dose groups, 15U/20U of incobotulinumtoxinA were injected into each submandibular gland, and 22.5U/30U into each parotid gland. Study duration was 16±2 weeks post-injection. Co-primary outcomes: Unstimulated Salivary Flow Rate (uSFR) at week 4 vs baseline and Global Impression of Change Scale (GICS) at week 4 post-injection. Secondary assessments: Drooling Severity and Frequency Scale (DSFS) and modified Radboud Oral Motor Inventory in Parkinson’s Disease (mROMP)-drooling. Adverse events were monitored throughout. Results: 184 subjects were randomized to 3 treatment groups: 75U (n=74), 100U (n=74), or placebo (n=36). Sialorrhea etiologies: PD (70.6%), stroke (17.9%), atypical Parkinson syndromes (8.7%), traumatic brain injury (2.7%). At week 4, the LS-mean uSFR reduction for the 100U group was −0.13 g/min (SE 0.026, 95%CI); the LS-mean GICS improvement was +1.25 points (SE 0.144, 95%CI) at week 4. Both co-primary outcomes were significantly greater in the 100U dose group vs placebo at week 4 ( P Conclusions: IncobotulinumtoxinA is effective for treating of sialorrhea in PD and other neurological conditions through 16 weeks. A greater improvement was observed at the 100U dose without meaningful increased safety risks. Study Supported by: Study sponsored by Merz Pharmaceuticals GmbH. Disclosure: Dr. Blitzer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merz. Dr. Blitzer has received research support from Merz. Dr. Friedman has received research support from Merz. Dr. Michel has received research support from Merz. Dr. Flatau-Baque has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merz. Dr. Csikos has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merz. Dr. Jost has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan plc, Ipsen, and Merz." @default.
- W2806417025 created "2018-06-13" @default.
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- W2806417025 date "2018-04-10" @default.
- W2806417025 modified "2023-09-25" @default.
- W2806417025 title "SIAXI: IncobotulinumtoxinA for sialorrhea in Parkinson’s disease, stroke, and other etiologies-Phase 3 Results (S30.007)" @default.
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