Abstract Details

Title Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects

Topic Movement Disorders

Presentation(s) Movement Disorders Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 129

Objective To confirm the efficacy and safety of incobotulinumtoxinA (INCO) in Japanese subjects from study sites in Japan with post-stroke spasticity in the lower limb (LL), using the Modified Ashworth Scale (MAS) spasticity score for the plantar flexors.

Background

INCO is a purified botulinum toxin type A formulation, free from complexing proteins.

Design/Methods This phase III, prospective, double-blind, placebo-controlled, randomized, study (CTI-153030) started with an open-label lead-in tolerability period (LITP) comprised of one injection cycle. The investigators assessed INCO tolerability as either “good” or “very good” for all subjects in LITP. The efficacy of INCO (400 U) vs placebo in subjects with post-stroke LL spasticity was confirmed by means of area under the curve (AUC) of changes in plantar flexor MAS spasticity score throughout the Main Period (MP). At the end of LITP, a decision was made based on a safety assessment by an Independent Data Monitoring Committee to continue in the MP with 400 U.

Results A total of 208 subjects were enrolled in MP and randomized to receive one injection of INCO (n=104), or placebo (n=104) into LL muscles. Changes in MAS plantar flexor score in both groups from baseline to week 1, 4, 6, 8, and 12 were assessed and compared. Eleven subjects were enrolled in LITP and received one injection of 400 U INCO. INCO subjects’ AUC of mean changes from baseline in the MAS plantar flexor score was statistically significant compared to placebo [LS-mean: -8.40 and -5.81; respectively (p=0.0041)]. The largest improvement was seen at week 6.

Conclusions This study confirmed the efficacy of INCO in a Japanese population with LL spasticity, and showed that INCO at the dose of 400 U had a favorable safety and tolerability profile in this population. No safety concerns were observed with INCO treatment.

Authors/Disclosures
PRESENTER	No disclosure on file
	No disclosure on file
	No disclosure on file
Ryuji Kaji, MD, FAAN (Tokushima University Graduate School of Medicine)	Dr. Kaji has nothing to disclose.

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