ong-term Study of BOTOX® Treatment in Adult Patients with Upper Limb Spasticity

Phase 1

Conditions: Poststroke spasticity involving the muscles of the elbow and shoulder in adult patients
MedDRA version: 20.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852
MedDRA version: 20.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 100000004852
MedDRA version: 20.0 Level: LLT Classification code 10048970 Term: Arm spasticity System Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-002327-42-GB

Lead Sponsor: Allergan Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

For patients who directly rollover from Study 191622-127:
• patient has fulfilled Study 191622-127 exit criteria: either met qualification for retreatment criteria or completed week-16 visit (if they never qualified for retreatment)
• patient has not experienced an adverse event or developed a medical condition (eg, breathing difficulties) that, based on the investigator’s clinical judgment, may indicate an unacceptable safety risk for additional BOTOX treatments
• patient has not experienced a treatment-related serious adverse event in Study 191622-127
• negative urine pregnancy test for all female patients of childbearing potential

For de novo patients:
• male or female aged = 18 to = 80 years
• score of = 2 on the MAS-B in the elbow flexors at both the screening and day 1 visits
• score of = 2 on the MAS-B in the shoulder adductors (of the same limb with elbow spasticity) at both the 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 into the muscles of the elbow and shoulder of a single upper limb
• negative urine pregnancy test for all female patients of childbearing potential
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 284
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 116

Exclusion Criteria

• patients with spasticity in the contralateral upper limb that requires treatment, in the opinion of the investigator
• 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 of 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 increased risk of 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 mediations that might interfere with neuromuscular function
• patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To evaluate the long-term safety and efficacy of repeated doses of 300 U and 500 U BOTOX<br> for the treatment of adult upper limb spasticity.<br> ;Secondary Objective: NA;<br> Primary end point(s): The key efficacy measure is MAS-B of the treated muscle group(s) of the<br> upper limb<br> ;Timepoint(s) of evaluation of this end point: The MAS-B change from baseline to each post randomization visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary endpoints specified. All Efficacy and Safety variables will be summarised.;Timepoint(s) of evaluation of this end point: Efficacy and safety variables will be evaluated at each measured timepoint.

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