Poststroke spasticity involving the muscles of the elbow and shoulder in adult patients MedDRA version: 17.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 MedDRA version: 17.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 100000004852 MedDRA version: 17.0 Level: LLT Classification code 10048970 Term: Arm spasticity System Organ Class: 100000004852
Conditions
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Main Objective: To evaluate the safety and efficacy of BOTOX 300 U and 500 U in the treatment of spasticity involving the muscles of the elbow and shoulder of adult poststroke patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • MAS-B of the shoulder adductors (change from baseline) • Pain scale (11-point numeric rating scale [NRS]) (change from baseline) • Disability Assessment Scale (DAS): principal therapeutic intervention target (PTIT) (change from baseline);Timepoint(s) of evaluation of this end point: • Week 6 • The secondary variables will also be evaluated at all other post-treatment visits | — |
Countries
Canada, Czech Republic, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Singapore, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactAllergan Ltd. EU Regulatory Affairs
Allergan Limited
Outcome results
None listed