BOTOX® provided significant MAS* improvements

Pediatric Upper Limb Spasticity Muscle Tone
(elbow/wrist flexors)

Co-primary endpoint: Mean change from baseline in principal muscle group (elbow or wrist) MAS (weeks 4 and 6 average)­

Pediatric Lower Limb Spasticity Muscle Tone1, *
(ankle plantar flexors)

Co-primary endpoint: Mean change from baseline in principal muscle group (ankle plantar flexors) MAS (weeks 4 and 6 average)

Fast onset Both pivotal studies demonstrated noticeable results within 2 weeks, with peak clinical effect as early as 4 weeks1,2

*MAS = Modified Ashworth Scale.

Clinical study design

Study 1: Pediatric Upper Limb Spasticity

Randomized, multicenter, double-blind, placebo-controlled in pediatric patients 2-17 years old with upper limb spasticity (MAS elbow or wrist score >/= 2) because of cerebral palsy or stroke

PATIENTS BOTOX® DOSAGE CO-PRIMARY
ENDPOINTS
N = 234 BOTOX®
(n = 155)
Placebo
(n = 79)
3 Units/kg (n = 78) Mean change from baseline in MAS*,4 principal muscle group (elbow/wrist score), weeks 4 and 6 average
6 Units/kg (n = 77) Mean CGI†,4 score (weeks 4 and 6 average)

Study 2: Pediatric Lower Limb Spasticity

Randomized, multicenter, double-blind, placebo-controlled in pediatric patients 2-17 years old with lower limb spasticity (MAS ankle score >/= 2) because of cerebral palsy

PATIENTS BOTOX® DOSAGE CO-PRIMARY
ENDPOINTS
N = 381 BOTOX®
(n = 252)
Placebo
(n = 129)
4 Units/kg (n = 125) Mean change from baseline in MAS*,4 principal muscle group (ankle plantar flexors), weeks 4 and 6 average
8 Units/kg (n = 127) Mean CGI†,4 score (weeks 4 and 6 average)

The Clinical Global Impression of Overall Change by Physician (CGI) evaluated the response to treatment in terms of how the patient was doing in his/her life using a 9-point scale (-4 = very marked worsening to +4 = very marked improvement).

The Clinical Global Impression (CGI) scores further illustrate treatment benefit

Pediatric Upper Limb Spasticity3
Treatment Response

Co-primary endpoint: Mean CGI score (Weeks 4 and 6 average). Results numerically favored BOTOX® vs placebo at all time points (Weeks 2 to 12), but the difference was not statistically significant.

Co-primary endpoint: Mean CGI score (Weeks 4 and 6 average). Results numerically favored BOTOX® vs placebo at all time points (Weeks 2 to 12), but the difference was not statistically significant.

Pediatric Lower Limb Spasticity3
Treatment Response
Improved CGI All patients received weekly physical/occupational therapy (PT/OT), but the BOTOX® groups showed greater improvements vs placebo across all time points1,2,*,‡,§

Patients received weekly PT in the Pediatric LLS study and weekly OT in the Pediatric ULS study.

§CGI scores in the Pediatric ULS study numerically favored BOTOX® vs placebo, but the difference was not statistically significant. In the Pediatric LLS study, CGI scores were statistically significant for the BOTOX® 8 Units/kg group only.

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