Abstract Details

Title A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia

Topic Movement Disorders

Presentation(s) P12 - Poster Session 12 (5:30 PM-6:30 PM)

Poster/Presentation
Number 5-002

Background DAXI is a novel botulinumtoxinA with a proprietary peptide excipient. ASPEN-1, a Phase 3 double blind-placebo controlled study demonstrated efficacy and duration of effect in CD. We report results of open-label safety and efficacy from a large, multicenter, Phase 3 open-label trial of up to 4 continuous treatments of DAXI.

Objective To evaluate the long-term safety of multiple continuous treatments of daxibotulinumtoxinA for injection (DAXI) in subjects with cervical dystonia (CD).

Design/Methods Adult with moderate to severe CD were recruited from study centers in the US, Canada, and Europe who were enrolled in ASPEN-1. Additional botulinum toxin (BoNT) treatment-naïve or -experienced adult subjects not enrolled in ASPEN-1 were also enrolled. At baseline, using predefined criteria the investigator selected an open-label dose of DAXI 125 U or 250 U for the subject based on clinical factors, CD severity, and BoNT treatment history. The investigator identified muscles for injection based on clinical presentation (e.g., head, neck, and shoulder position, localization of pain, and muscle hypertrophy). The volume injected per muscle for each dose level was within a predefined dose range per muscle. During each treatment cycle subjects had visits at Weeks 4, 6, 12, and every 4 weeks thereafter up to Week 52 or end of study to assess safety and tolerability. Retreatment was based on loss of 80% of peak treatment effect, or subject request and investigator judgment.

Results

Of the 387 subjects screened, 358 subjects were enrolled: 272 (76.0%) rollover from ASPEN-1 and 86 (24.0%) de novo. Topline safety and efficacy results will be presented.

Conclusions

Topline safety and efficacy results will be presented.

Authors/Disclosures
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache) PRESENTER	Dr. McAllister has received personal compensation for serving as an employee of Revance. Dr. McAllister has received personal compensation for serving as an employee of AbbVie. Dr. McAllister has received personal compensation for serving as an employee of Merz. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for teva. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for biohaven. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
Jaroslaw Slawek, MD	No disclosure on file
	No disclosure on file
Daniel D. Truong, MD, FAAN (PMDI)	The institution of Dr. Truong has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. The institution of Dr. Truong has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. The institution of Dr. Truong has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. The institution of Dr. Truong has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Truong has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Truong has received research support from Abbvie. The institution of Dr. Truong has received research support from Aeon. The institution of Dr. Truong has received research support from Biogen. The institution of Dr. Truong has received research support from Bukwang. The institution of Dr. Truong has received research support from Cerevel. The institution of Dr. Truong has received research support from Eli Lilly. The institution of Dr. Truong has received research support from Enterin. The institution of Dr. Truong has received research support from Ipsen. The institution of Dr. Truong has received research support from Lundbeck. The institution of Dr. Truong has received research support from Neurocrine. The institution of Dr. Truong has received research support from Neuroderm. The institution of Dr. Truong has received research support from Parkinson Foundation. The institution of Dr. Truong has received research support from Prilenia. The institution of Dr. Truong has received research support from Revance. The institution of Dr. Truong has received research support from Sunovion. Dr. Truong has received publishing royalties from a publication relating to health care. Dr. Truong has received publishing royalties from a publication relating to health care. Dr. Truong has a non-compensated relationship as a President with International Association for Parkinsonism and Related Disorders that is relevant to AAN interests or activities.
Todd Gross (Revance)	Todd Gross has received personal compensation for serving as an employee of Revance Therapeutics Inc. Todd Gross has stock in Revance Therapeutics Inc.
Roman Rubio	Roman Rubio has received personal compensation for serving as an employee of Revance.
James P. Kesslak, PhD (Alzheon)	Dr. Kesslak has received personal compensation for serving as an employee of Alzheon. Dr. Kesslak has stock in Prime First Lending.
Domenico Vitarella (Revance)	No disclosure on file