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
216 participants
INTERVENTIONAL
2007-02-28
2008-05-31
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
SINGLE
Study Groups
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incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 5.0 mL resulted in a dose of 20 units per 1.0 mL.
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 mL sterile of NaCl 0.9% solution without preservatives. Dilution with 2.0 mL resulted in a dose of 50 units per 1.0 mL.
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.
Interventions
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incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable upper limb spasticity of diverse etiology
* Focal spasticity with equal or more than 2 points on the Ashworth scale in the wrist flexors
* Disability Assessment Scale (DAS) ≥ 2 points for primary therapeutic target at both screening and baseline visits
Exclusion Criteria
* Bilateral upper limb paresis/paralysis
* Previous treatment with BoNT of any serotype and for any body region within the 4 months prior to screening
* Previous or planned treatment with phenol- or alcohol-injection in the target limb
* Other muscle hypertonia (e.g. rigidity)
* Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
* Severe atrophy of the target limb muscles
18 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Merz Pharmaceuticals GmbH
Principal Investigators
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Michael P Barnes, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Hunters Moor Hospital, Newcastle-upon-Tyne, UK
Locations
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Hermagor, , Austria
Innsbruck, , Austria
Vienna, , Austria
Besançon, , France
Garches, , France
Lille, , France
Paris, , France
Beelitz-Heilstätten, , Germany
Düsseldorf, , Germany
Gladbeck, , Germany
Bari, , Italy
Costa Masnaga, , Italy
Messina, , Italy
Mestre, , Italy
Milan, , Italy
Rome, , Italy
Lisbon, , Portugal
Tocha, , Portugal
Barcelona, , Spain
Madrid, , Spain
Terrassa, , Spain
Bern, , Switzerland
Nottwil, , Switzerland
Kent, , United Kingdom
Liverpool, , United Kingdom
Plymouth, , United Kingdom
Wakefield, , United Kingdom
Countries
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Other Identifiers
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MRZ 60201 - 0607 / 1
Identifier Type: -
Identifier Source: org_study_id