好色先生

好色先生

Explore the latest content from across our publications

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Long-term Safety and Efficacy of IncobotulinumtoxinA for the Treatment of Blepharospasm in Botulinum Toxin-naive Subjects: Results of a Phase III Study
Neuro-ophthalmology/Neuro-otology
S28 - Neuro-ophthalmology/Neuro-otology (4:14 PM-4:25 PM)
005
IncobotulinumtoxinA is efficacious for BEB. This was the first, randomized, Phase III study (NCT01896895) in toxin-naïve subjects. Here we present data from the complete study.
 

To assess the safety and efficacy of incobotulinumtoxinA for benign essential blepharospasm (BEB) in toxin-naïve subjects.

Subjects (18–80 years) with bilateral BEB, Jankovic Rating Scale (JRS) severity subscore ≥2, and no BEB treatment with any botulinum neurotoxin (BoNT) serotype within past ≥12 months, were enrolled. In the main period (MP), subjects were randomized (1:1:1) in a double-blind manner to single intramuscular injections of incobotulinumtoxinA 25U (12.5U/eye), 50U (25U/eye) or placebo, with an observation period (OP) of 6–20 weeks. Subjects with a need for re-injection (JRS severity subscore ≥2 at final MP visit) were eligible for the open-label extension period (EP): a single dose of incobotulinumtoxinA ≤70U (≤35U/eye) with a 6–20-week OP. Mean change from baseline in JRS severity subscore and safety were assessed.   

Overall, 61 subjects were randomized (mean 55.0 years; 59.0% female); 55 completed the MP and 39 entered and completed the EP. At MP Week 6, JRS severity subscore significantly improved from baseline with incobotulinumtoxinA 50U versus placebo (p=0.0004), and numerically improved with incobotulinumtoxinA 25U versus placebo. Sustained improvements were seen with incobotulinumtoxinA ≤70U from EP baseline to EP Week 6 (–1.2) and to EP final visit (–0.7), and from MP baseline to EP final visit (–1.0) (all p<0.0001).  In the MP, more adverse events (AEs) were reported with incobotulinumtoxinA 50U (42.1%) versus 25U (31.8%) or placebo (30.0%). AEs were less frequent in the EP (all incobotulinumtoxinA-treated: 28.2%). Most AEs were of mild-to-moderate severity.

IncobotulinumtoxinA showed sustained efficacy in toxin-naïve subjects with BEB. Long-term safety results were in line with the known safety profile.

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.
Dimos Dimitrios D. Mitsikostas, MD, PhD (National and Kapodistrian University of Athens) The institution of Dr. Mitsikostas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. The institution of Dr. Mitsikostas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. The institution of Dr. Mitsikostas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. The institution of Dr. Mitsikostas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Leli Lilly. The institution of Dr. Mitsikostas has received research support from Eli Lilly. Dr. Mitsikostas has a non-compensated relationship as a Co-Chair of Headache Panel with EAN that is relevant to AAN interests or activities. Dr. Mitsikostas has a non-compensated relationship as a President with Hellenic Headache Society that is relevant to AAN interests or activities. Dr. Mitsikostas has a non-compensated relationship as a Associate Editor with J Headache Pain that is relevant to AAN interests or activities. Dr. Mitsikostas has a non-compensated relationship as a Associate Editor with Frontier Neurology that is relevant to AAN interests or activities.
No disclosure on file
No disclosure on file
Michael Althaus (Merz Pharmaceuticals GmbH) Michael Althaus has received personal compensation for serving as an employee of Merz Pharmaceuticals.