Post-stroke Spasticity of the Lower Limb Clinical Trial
— PLUSOfficial title:
Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb
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.
| Status | Completed |
| Enrollment | 290 |
| Est. completion date | May 2015 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Age from 18-80 yrs - Lower limb spasticity - Time since stroke greater than 3 months - Need for 400 U Botulinum toxin type A Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Merz Investigational Site #001204 | Halifax | Nova Scotia |
| Canada | Merz Investigational Site #001202 | Winnipeg | |
| Czech Republic | Merz Investigational Site #420024 | Ostrava-Poruba | |
| Czech Republic | Merz Investigational Site #420031 | Ostrava-Vitkovice | |
| Czech Republic | Merz Investigational Site #420030 | Praha | |
| Czech Republic | Merz Investigational Site #420047 | Rychnov nad Kneznou | |
| France | Merz Investigational Site #033018 | Garches | |
| France | Merz Investigational Site #033024 | Rennes | |
| Germany | Merz Investigational Site #049022 | Beelitz-Heilstätten | |
| Germany | Merz Investigational Site #049071 | Düsseldorf | |
| Germany | Merz Investigational Site #049079 | Hamburg | |
| Germany | Merz Investigational Site #049304 | Kiel | |
| Germany | Merz Investigational Site #049072 | München | |
| Germany | Merz Investigational Site #049148 | München | |
| Germany | Merz Investigational Site #049303 | Regensburg | |
| Germany | Merz Investigational Site #049302 | Würzburg | |
| Italy | Merz Investigational Site #039006 | Messina | |
| Italy | Merz Investigational Site #039011 | Roma | |
| Italy | Merz Investigational Site #039012 | Roma | |
| Poland | Merz Investigational Site #048057 | Gdansk | |
| Poland | Merz Investigational Site #048044 | Kielce | |
| Poland | Merz Investigational Site #048031 | Krakow | |
| Poland | Merz Investigational Site #048054 | Krakow | |
| Poland | Merz Investigational Site #048080 | Krakow | |
| Poland | Merz Investigational Site #048022 | Lodz | |
| Poland | Merz Investigational Site #048051 | Lublin | |
| Poland | Merz Investigational Site #048053 | Poznan | |
| Poland | Merz Investigational Site #048081 | Poznan | |
| Poland | Merz Investigational Site #048023 | Warszawa | |
| Poland | Merz Investigational Site #048033 | Warszawa | |
| Poland | Merz Investigational Site #048055 | Warszawa | |
| Poland | Merz Investigational Site #048056 | Warszawa | |
| Russian Federation | 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 #007012 | Stavropol | |
| Spain | Merz Investigational Site #034027 | Madrid | |
| Spain | Merz Investigational Site #034028 | Majadahonda | |
| Spain | Merz Investigational Site #034026 | Sevilla | |
| Spain | Merz Investigational Site #034030 | Sevilla | |
| Spain | Merz Investigational Site #034029 | Terrassa | |
| United States | Merz Investigational Site #001209 | Columbia | Missouri |
| United States | Investigational site #001188 | Doral | Florida |
| United States | Merz Investigational Site #001184 | Downey | California |
| United States | Merz Investigational Site #001244 | Fairfield | Connecticut |
| United States | Merz Investigational Site #001183 | Houston | Texas |
| United States | Merz Investigational Site #001208 | Long Beach | California |
| United States | Merz Investigational Site #001206 | Nashville | Tennessee |
| United States | Merz Investigational Site # 001110 | Overland Park | Kansas |
| United States | Merz Investigational Site #001207 | Plainview | New York |
| United States | Merz Investigational Site #001210 | St. Louis | Missouri |
| United States | Merz Investigational Site #001198 | Stratford | New Jersey |
| United States | Merz Investigational Site #001009 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Merz Pharmaceuticals GmbH |
United States, Canada, Czech Republic, France, Germany, Italy, Poland, Russian Federation, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Baseline and Week 4 | No |
| Primary | 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. | Baseline to Week 12 | No |
| Secondary | 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). | Week 4, 8, and 12 | No |
| Secondary | 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. | Baseline, Week 4, 8, and 12 | No |