Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
- Conditions
- Post-stroke Spasticity of the Upper Limb
- Interventions
- Drug: Placebo ComparatorDrug: IncobotulinumtoxinA (400 Units)
- Registration Number
- NCT01392300
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 317
- Upper limb spasticity
- Time since stroke greater than 3 months
- Need for 400 U Botulinum toxin type A
- Body weight below 50kg
- Fixed contractures of the upper limb
- Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A
- Infection at the injection site
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DB Placebo Comparator Placebo Comparator Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment DB IncobotulinumtoxinA (Xeomin) (400 U) IncobotulinumtoxinA (400 Units) IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment
- Primary Outcome Measures
Name Time Method Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern Week 4 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).Investigator's Global Impression of Change Week 4 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.
- Secondary Outcome Measures
Name Time Method Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow Week 4 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.
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow Week 8 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.
Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern Week 4 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.
Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern Week 8 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.
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist Week 8 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.
Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern Week 12 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.
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist Week 12 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.
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist Week 4 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.
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow Week 12 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.
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist Week 4 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.
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist Week 8 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.
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist Week 12 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.
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm Week 4 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.
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm Week 8 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.
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm Week 12 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.
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm Week 4 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.
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm Week 8 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.
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm Week 12 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.
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. Week 4 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).
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. Week 8 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).
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. Week 12 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).
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. Week 4 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).
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. Week 8 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).
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. Week 12 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).
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. Week 4 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).
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. Week 8 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).
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. Week 12 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).
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. Week 4 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).
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. Week 8 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).
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. Week 12 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).
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. Week 4 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).
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. Week 8 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).
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. Week 12 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).
Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain Week 4 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).
Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain Week 8 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).
Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain Week 12 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).
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene Week 4 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).
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene Week 8 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).
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene Week 12 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).
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing Week 4 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).
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing Week 8 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).
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing Week 12 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).
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position Week 4 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).
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position Week 8 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).
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position Week 12 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).
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain Week 4 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).
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain Week 8 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).
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain Week 12 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).
Trial Locations
- Locations (47)
Merz Investigational Site # 001110
🇺🇸Overland Park, Kansas, United States
Merz Investigational Site #001245
🇺🇸Chattanooga, Tennessee, United States
Merz Investigational Site #420030
🇨🇿Praha, Czech Republic
Merz Investigational Site #048053
🇵🇱Poznan, Poland
Merz Investigational Site #091007
🇮🇳Chennai, Tamil Nadu, India
Merz Investigational Site #091008
🇮🇳Coimbatore, Tamil Nadu, India
Merz Investigational Site #001188
🇺🇸Miami, Florida, United States
Merz Investigational Site # 048029
🇵🇱Gdansk, Poland
Merz Investigational Site #001017
🇺🇸Fountain Valley, California, United States
Merz Investigational Site #001184
🇺🇸Downey, California, United States
Merz Investigational Site #001186
🇺🇸Chicago, Illinois, United States
Merz Investigational Site #001037
🇺🇸Augusta, Georgia, United States
Merz Investigational Site #001198
🇺🇸Stratford, New Jersey, United States
Merz Investigational Site #001211
🇺🇸Pittsburgh, Pennsylvania, United States
Merz Investigational Site #001226
🇺🇸Houston, Texas, United States
Merz Investigational Site #420046
🇨🇿Brno, Czech Republic
Merz Investigational Site #420029
🇨🇿Brno, Czech Republic
Merz Investigational Site #420028
🇨🇿Olomouc, Czech Republic
Merz Investigational Site #420024
🇨🇿Ostrava-Poruba, Czech Republic
Merz Investigational Site #420025
🇨🇿Pardubice, Czech Republic
Merz Investigational Site #420045
🇨🇿Praha, Czech Republic
Merz Investigational Site #420047
🇨🇿Rychnov nad Kneznou, Czech Republic
Merz Investigational Site #036004
🇭🇺Budapest, Hungary
Merz Investigational Site # 036009
🇭🇺Budapest, Hungary
Merz Investigational Site #049134
🇩🇪Rostock, Germany
Merz Investigational Site #036005
🇭🇺Nyiregyhaza, Hungary
Merz Investigational Site #091006
🇮🇳Bangalore, Karnataka, India
Merz Investigational Site #036008
🇭🇺Szeged, Hungary
Merz Investigational Site #091003
🇮🇳Porur, Chennai, India
Merz Investigational Site #091002
🇮🇳Trivandrum, Kerala, India
Merz Investigational Site #091001
🇮🇳Lucknow, Uttar Pradesh, India
Merz Investigational Site #091004
🇮🇳New Delhi, India
Merz Investigational Site #048044
🇵🇱Kielce, Poland
Merz Investigational Site #048050
🇵🇱Lodz, Poland
Merz Investigational Site #048051
🇵🇱Lublin, Poland
Merz Investigational Site #048031
🇵🇱Krakow, Poland
Merz Investigational Site #048032
🇵🇱Olsztyn, Poland
Merz Investigational Site #048023
🇵🇱Warszawa, Poland
Merz Investigational Site #048052
🇵🇱Warszawa, Poland
Merz Investigational Site #048033
🇵🇱Warszawa, Poland
Merz Investigational Site #007010
🇷🇺Krasnoyarsk, Russian Federation
Merz Investigational Site #007011
🇷🇺Moscow, Russian Federation
Merz Investigational Site #007009
🇷🇺St. Petersburg, Russian Federation
Merz Investigational Site #007005
🇷🇺Stavropol, Russian Federation
Merz Investigational Site #001240
🇺🇸Chapel Hill, North Carolina, United States
Merz Investigational Site #001241
🇺🇸Philadelphia, Pennsylvania, United States
Merz Investigational Site #001009
🇺🇸Winston-Salem, North Carolina, United States