The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
317
Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection
Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Investigator's Global Impression of Change
This is the co-primary outcome measure. The Global Impression of Change Scale \[GICS\] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
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Merz Investigational Site #001184
Downey, California, United States
Merz Investigational Site #001017
Fountain Valley, California, United States
Merz Investigational Site #001188
Miami, Florida, United States
Merz Investigational Site #001037
Augusta, Georgia, United States
Merz Investigational Site #001186
Chicago, Illinois, United States
Merz Investigational Site # 001110
Overland Park, Kansas, United States
Merz Investigational Site #001198
Stratford, New Jersey, United States
Merz Investigational Site #001240
Chapel Hill, North Carolina, United States
Merz Investigational Site #001009
Winston-Salem, North Carolina, United States
Merz Investigational Site #001241
Philadelphia, Pennsylvania, United States
...and 37 more locations
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12