BOTOX® Treatment in Adult Patients with Upper Limb Spasticity

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 423

Inclusion Criteria

• male or female, = 18 to = 80 years of age at screening visit with upper limb spasticity due to stroke
• MAS-B score of = 3 in the elbow flexors at both screening and day-1 visits
• MAS-B score of = 3 in the shoulder adductors (of the same limb with elbow flexor spasticity) at
both screening and day-1 visits
• minimum body weight of 50 kg (110 pounds) at the screening visit
• in the opinion of the investigator, the patient has sufficient spasticity to warrant a total BOTOX
dose of 500 U divided among elbow and shoulder muscles of the same limb
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 123

Exclusion Criteria

• patients with spasticity in the contralateral upper limb that requires treatment
• presence of fixed contractures of the study muscles of the elbow or shoulder
• previous surgical intervention, phenol block, ethanol block, or muscle afferent block for the
treatment of spasticity in the study muscles in either the elbow or shoulder, within 12 months prior
to the day-1 visit or planned during the study
• presence or history (within 12 months prior to the day-1 visit) of aspiration pneumonia, recurrent
lower respiratory tract infections, uncontrolled asthma, uncontrolled chronic obstructive
pulmonary disease, or significantly compromised respiratory function, that may indicate a
vulnerable respiratory state, per the investigator’s clinical judgment
• presence or history (within 12 months prior to the day-1 visit) of aspiration or a condition(s) that,
in the investigator’s opinion, may put the patient at an increased risk for aspiration (eg, significant
drooling, chronic dysphagia [difficulty swallowing] requiring changes in diet)
• intraarticular injection of corticosteroids or anesthetics in the elbow or shoulder of the study limb
within 3 months prior to the day-1 visit or planned during the study
• any medical or neurological condition that may put the patient at increased risk with exposure to
BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
sclerosis, or any other significant diseases or concomitant medications that might interfere with
neuromuscular function

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and efficacy of BOTOX 300 U and 500 U in the treatment of spasticity<br>involving the muscles of the elbow and shoulder of adult poststroke patients.;Secondary Objective: NA;Primary end point(s): Change from baseline in the MAS-B elbow flexors.;Timepoint(s) of evaluation of this end point: Week 6. The primary variable will also be evaluated at all other post-treatment visits.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • MAS-B of the shoulder adductors (change from baseline)<br>• Pain scale (11-point numeric rating scale [NRS]) (change from baseline)<br>• Disability Assessment Scale (DAS): principal therapeutic intervention target (PTIT) <br>(change from baseline);Timepoint(s) of evaluation of this end point: • Week 6<br>• The secondary variables will also be evaluated at all other post-treatment visits