The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
290
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) for Plantar Flexors at Week 4
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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: Baseline and Week 4
Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12
A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.
Time frame: Baseline to Week 12
Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)
Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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, 8, and 12
Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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). Here, 'n' specifies those subjects who were evaluated for this outcome measure at given time point.
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Merz Investigational Site #001184
Downey, California, United States
Merz Investigational Site #001208
Long Beach, California, United States
Merz Investigational Site #001244
Fairfield, Connecticut, United States
Investigational site #001188
Doral, Florida, United States
Merz Investigational Site # 001110
Overland Park, Kansas, United States
Merz Investigational Site #001209
Columbia, Missouri, United States
Merz Investigational Site #001210
St Louis, Missouri, United States
Merz Investigational Site #001198
Stratford, New Jersey, United States
Merz Investigational Site #001207
Plainview, New York, United States
Merz Investigational Site #001009
Winston-Salem, North Carolina, United States
...and 43 more locations
Time frame: Baseline, Week 4, 8, and 12