Abstract Details

Title Long-term Efficacy and Safety of IncobotulinumtoxinA Treatment for Sialorrhea

Topic Movement Disorders

Presentation(s) S4 - Clinical Trials in Movement Disorders (2:06 PM-2:17 PM)

Poster/Presentation
Number 007

Background SIAXI (NCT02091739), was a randomized, double-blind, placebo-controlled, 16-week Phase III study with a 48-week extension period (EP). Here we present data from the complete study.

Objective To assess the long-term efficacy and safety of incobotulinumtoxinA 75U and 100U in subjects with sialorrhea.

Design/Methods In the main period (MP), subjects with sialorrhea due to Parkinson’s disease, atypical Parkinsonism, stroke, or traumatic brain injury were randomized (2:2:1) to incobotulinumtoxinA 75U, 100U (n=74 each), or placebo (n=36) in a single injection cycle (IC). Eligible subjects entered the EP and received three incobotulinumtoxinA 75U or 100U ICs (16±2 week duration). Outcomes included: unstimulated salivary flow rate (uSFR), and scores on the subjects’ Global Impression of Change Scale (GICS), Drooling Severity and Frequency Scale (DSFS), modified Radboud Oral Motor Inventory for Parkinson’s disease (mROMP) (Kalf JG et al. Arch Phys Med Rehabil 2011; 92: 1152–1158) and EuroQoL 5-dimensions visual analog scale (EQ-5D VAS). Adverse events (AEs) were reported.

Results In total, 173/184 subjects completed the MP and entered the EP. In all ICs, uSFR decreased from study baseline with repeated ICs in incobotulinumtoxinA 75U- or 100U-treated subjects (mean [standard deviation] change from study baseline to end-of-study –0.16 [0.21] and –0.17 [0.23] g/min, respectively). Subjects’ GICS improved at all visits and DSFS, mROMP drooling scores, and EQ-5D VAS improved from study baseline to 4 weeks post-injection in each IC. mROMP speech and swallowing symptom scores remained stable. The most common treatment-related AEs for incobotulinumtoxinA 75U and 100U, respectively, were dry mouth (4.4% and 11.1%) and dysphagia (1.5% and 4.2%). Two subjects reported serious treatment-related AEs including speech disorder (one incobotulinumtoxinA 75U recipient) and dysphagia (one incobotulinumtoxinA 100U recipient).

Conclusions

These data support the long-term efficacy and safety of repeated incobotulinumtoxinA treatment for sialorrhea.

Authors/Disclosures
Fernando L. Pagan, MD, FAAN (Georgetown University Hospital Dept of Neurology) PRESENTER	Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Adamas. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for US World Meds. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Adamas. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurocrine. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Clinical Parkinsonism and related Disorders. Dr. Pagan has stock in Keiferx. The institution of Dr. Pagan has received research support from US World Meds. The institution of Dr. Pagan has received research support from Novartis.
Wolfgang Jost	No disclosure on file
Christian Oehlwein, MD	No disclosure on file
Jaroslaw Slawek, MD	No disclosure on file
	No disclosure on file
	No disclosure on file
Marta Banach, MD	Dr. Banach has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz Pharmaceuticals GmbH. Dr. Banach has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz Pharmaceuticals GmbH. Dr. Banach has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Merz Pharmaceuticals GmbH.
Janos Csikós	No disclosure on file
Andrew Blitzer, MD	No disclosure on file

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