Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
- Conditions
- Post-stroke Spasticity of the Lower Limb
- Interventions
- Drug: IncobotulinumtoxinA (400 Units)Drug: Placebo Comparator
- Registration Number
- NCT01464307
- 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 leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
- Age from 18-80 yrs
- Lower 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 lower 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 IncobotulinumtoxinA (Xeomin) 400 Units IncobotulinumtoxinA (400 Units) IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. Placebo Comparator Arm Placebo Comparator Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
- Primary Outcome Measures
Name Time Method Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4 Baseline and 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).
Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12 Baseline to 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.
- Secondary Outcome Measures
Name Time Method 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) Week 4, 8, and 12 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).
Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits Baseline, Week 4, 8, and 12 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.
Trial Locations
- Locations (53)
Merz Investigational Site #420024
🇨🇿Ostrava-Poruba, Czech Republic
Merz Investigational Site #001208
🇺🇸Long Beach, California, United States
Merz Investigational Site #001204
🇨🇦Halifax, Nova Scotia, Canada
Merz Investigational Site #001183
🇺🇸Houston, Texas, United States
Merz Investigational Site #001184
🇺🇸Downey, California, United States
Merz Investigational Site #001244
🇺🇸Fairfield, Connecticut, United States
Merz Investigational Site #001207
🇺🇸Plainview, New York, United States
Merz Investigational Site #420047
🇨🇿Rychnov nad Kneznou, Czech Republic
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 #001009
🇺🇸Winston-Salem, North Carolina, United States
Merz Investigational Site #001206
🇺🇸Nashville, Tennessee, United States
Merz Investigational Site #420031
🇨🇿Ostrava-Vitkovice, Czech Republic
Merz Investigational Site #033018
🇫🇷Garches, France
Merz Investigational Site #049071
🇩🇪Düsseldorf, Germany
Merz Investigational Site #049072
🇩🇪München, Germany
Merz Investigational Site #420030
🇨🇿Praha, Czech Republic
Merz Investigational Site #001202
🇨🇦Winnipeg, Canada
Merz Investigational Site #033024
🇫🇷Rennes, France
Merz Investigational Site #049022
🇩🇪Beelitz-Heilstätten, Germany
Merz Investigational Site #048044
🇵🇱Kielce, Poland
Merz Investigational Site #048053
🇵🇱Poznan, Poland
Merz Investigational Site #048023
🇵🇱Warszawa, Poland
Merz Investigational Site #049079
🇩🇪Hamburg, Germany
Merz Investigational Site #039006
🇮🇹Messina, Italy
Merz Investigational Site #049303
🇩🇪Regensburg, Germany
Merz Investigational Site #049148
🇩🇪München, Germany
Merz Investigational Site #049304
🇩🇪Kiel, Germany
Merz Investigational Site #048080
🇵🇱Krakow, Poland
Merz Investigational Site #039012
🇮🇹Roma, Italy
Merz Investigational Site #039011
🇮🇹Roma, Italy
Merz Investigational Site #048031
🇵🇱Krakow, Poland
Merz Investigational Site #007010
🇷🇺Krasnoyarsk, Russian Federation
Merz Investigational Site #034027
🇪🇸Madrid, Spain
Merz Investigational Site #007009
🇷🇺St. Petersburg, Russian Federation
Merz Investigational Site #034030
🇪🇸Sevilla, Spain
Merz Investigational Site #034028
🇪🇸Majadahonda, Spain
Merz Investigational Site #034026
🇪🇸Sevilla, Spain
Merz Investigational Site #007012
🇷🇺Stavropol, Russian Federation
Merz Investigational Site #001198
🇺🇸Stratford, New Jersey, United States
Merz Investigational Site #048057
🇵🇱Gdansk, Poland
Merz Investigational Site #049302
🇩🇪Würzburg, Germany
Merz Investigational Site #048051
🇵🇱Lublin, Poland
Merz Investigational Site #048054
🇵🇱Krakow, Poland
Merz Investigational Site #048022
🇵🇱Lodz, Poland
Merz Investigational Site #007011
🇷🇺Moscow, Russian Federation
Merz Investigational Site #034029
🇪🇸Terrassa, Spain
Merz Investigational Site #001210
🇺🇸St. Louis, Missouri, United States
Merz Investigational Site #048055
🇵🇱Warszawa, Poland
Merz Investigational Site #048033
🇵🇱Warszawa, Poland
Merz Investigational Site #048081
🇵🇱Poznan, Poland
Merz Investigational Site #048056
🇵🇱Warszawa, Poland