Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
NCT ID: NCT01464307
Last Updated: 2016-11-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
290 participants
INTERVENTIONAL
2011-12-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IncobotulinumtoxinA (Xeomin) 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.
IncobotulinumtoxinA (400 Units)
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.
Placebo Comparator Arm
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Placebo Comparator
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
Interventions
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IncobotulinumtoxinA (400 Units)
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.
Placebo Comparator
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
Eligibility Criteria
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Inclusion Criteria
* Lower limb spasticity
* Time since stroke greater than 3 months
* Need for 400 U Botulinum toxin type A
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals GmbH
Locations
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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
Merz Investigational Site #001206
Nashville, Tennessee, United States
Merz Investigational Site #001183
Houston, Texas, United States
Merz Investigational Site #001204
Halifax, Nova Scotia, Canada
Merz Investigational Site #001202
Winnipeg, , Canada
Merz Investigational Site #420024
Ostrava-Poruba, , Czechia
Merz Investigational Site #420031
Ostrava-Vitkovice, , Czechia
Merz Investigational Site #420030
Prague, , Czechia
Merz Investigational Site #420047
Rychnov nad Kněžnou, , Czechia
Merz Investigational Site #033018
Garches, , France
Merz Investigational Site #033024
Rennes, , France
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, , Germany
Merz Investigational Site #039006
Messina, , Italy
Merz Investigational Site #039011
Roma, , Italy
Merz Investigational Site #039012
Roma, , Italy
Merz Investigational Site #048057
Gdansk, , Poland
Merz Investigational Site #048044
Kielce, , Poland
Merz Investigational Site #048080
Krakow, , Poland
Merz Investigational Site #048054
Krakow, , Poland
Merz Investigational Site #048031
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 #048055
Warsaw, , Poland
Merz Investigational Site #048023
Warsaw, , Poland
Merz Investigational Site #048056
Warsaw, , Poland
Merz Investigational Site #048033
Warsaw, , Poland
Merz Investigational Site #007010
Krasnoyarsk, , Russia
Merz Investigational Site #007011
Moscow, , Russia
Merz Investigational Site #007009
Saint Petersburg, , Russia
Merz Investigational Site #007012
Stavropol, , Russia
Merz Investigational Site #034027
Madrid, , Spain
Merz Investigational Site #034028
Majadahonda, , Spain
Merz Investigational Site #034026
Seville, , Spain
Merz Investigational Site #034030
Seville, , Spain
Merz Investigational Site #034029
Terrassa, , Spain
Countries
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Other Identifiers
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2010-024579-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRZ 60201/SP/3002
Identifier Type: -
Identifier Source: org_study_id