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Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke (PURE)

Primary Purpose

Post-stroke Spasticity of the Upper Limb

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IncobotulinumtoxinA (400 Units)
Placebo Comparator
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Spasticity of the Upper Limb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Upper 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 upper limb
  • Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A
  • Infection at the injection site

Sites / Locations

  • Merz Investigational Site #001184
  • Merz Investigational Site #001017
  • Merz Investigational Site #001188
  • Merz Investigational Site #001037
  • Merz Investigational Site #001186
  • Merz Investigational Site # 001110
  • Merz Investigational Site #001198
  • Merz Investigational Site #001240
  • Merz Investigational Site #001009
  • Merz Investigational Site #001241
  • Merz Investigational Site #001211
  • Merz Investigational Site #001245
  • Merz Investigational Site #001226
  • Merz Investigational Site #420046
  • Merz Investigational Site #420029
  • Merz Investigational Site #420028
  • Merz Investigational Site #420024
  • Merz Investigational Site #420025
  • Merz Investigational Site #420030
  • Merz Investigational Site #420045
  • Merz Investigational Site #420047
  • Merz Investigational Site #049134
  • Merz Investigational Site #036004
  • Merz Investigational Site # 036009
  • Merz Investigational Site #036005
  • Merz Investigational Site #036008
  • Merz Investigational Site #091003
  • Merz Investigational Site #091006
  • Merz Investigational Site #091002
  • Merz Investigational Site #091007
  • Merz Investigational Site #091008
  • Merz Investigational Site #091001
  • Merz Investigational Site #091004
  • Merz Investigational Site # 048029
  • Merz Investigational Site #048044
  • Merz Investigational Site #048031
  • Merz Investigational Site #048050
  • Merz Investigational Site #048051
  • Merz Investigational Site #048032
  • Merz Investigational Site #048053
  • Merz Investigational Site #048023
  • Merz Investigational Site #048052
  • Merz Investigational Site #048033
  • Merz Investigational Site #007010
  • Merz Investigational Site #007011
  • Merz Investigational Site #007009
  • Merz Investigational Site #007005

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DB IncobotulinumtoxinA (Xeomin) (400 U)

DB Placebo Comparator

Arm Description

IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Outcomes

Primary Outcome Measures

Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
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
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

Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern
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
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 Primary Target Clinical Pattern
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 4 Calculated for the Muscle Group Flexed Wrist
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 Wrist
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 Wrist
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 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). 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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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).

Full Information

First Posted
July 7, 2011
Last Updated
November 29, 2016
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01392300
Brief Title
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
Acronym
PURE
Official 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 Upper Limb
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Spasticity of the Upper Limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DB IncobotulinumtoxinA (Xeomin) (400 U)
Arm Type
Experimental
Arm Description
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment
Arm Title
DB Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment
Intervention Type
Drug
Intervention Name(s)
IncobotulinumtoxinA (400 Units)
Other Intervention Name(s)
Xeomin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
Description
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).
Time Frame
Week 4
Title
Investigator's Global Impression of Change
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern
Description
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.
Time Frame
Week 4
Title
Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern
Description
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.
Time Frame
Week 8
Title
Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
Description
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.
Time Frame
Week 12
Title
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist
Description
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.
Time Frame
Week 4
Title
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist
Description
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.
Time Frame
Week 8
Title
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist
Description
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.
Time Frame
Week 12
Title
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow
Description
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.
Time Frame
Week 4
Title
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow
Description
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.
Time Frame
Week 8
Title
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow
Description
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.
Time Frame
Week 12
Title
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist
Description
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.
Time Frame
Week 4
Title
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist
Description
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.
Time Frame
Week 8
Title
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist
Description
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.
Time Frame
Week 12
Title
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm
Description
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.
Time Frame
Week 4
Title
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm
Description
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.
Time Frame
Week 8
Title
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm
Description
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.
Time Frame
Week 12
Title
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm
Description
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.
Time Frame
Week 4
Title
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm
Description
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.
Time Frame
Week 8
Title
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm
Description
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.
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position
Description
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).
Time Frame
Week 12
Title
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain
Description
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).
Time Frame
Week 4
Title
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain
Description
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).
Time Frame
Week 8
Title
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain
Description
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).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Upper 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 upper limb Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A Infection at the injection site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
Merz Pharmaceuticals GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Merz Investigational Site #001184
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Merz Investigational Site #001017
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92728
Country
United States
Facility Name
Merz Investigational Site #001188
City
Miami
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Merz Investigational Site #001037
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Merz Investigational Site #001186
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Merz Investigational Site # 001110
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Merz Investigational Site #001198
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Merz Investigational Site #001240
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Merz Investigational Site #001009
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Merz Investigational Site #001241
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Merz Investigational Site #001211
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Merz Investigational Site #001245
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Merz Investigational Site #001226
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Merz Investigational Site #420046
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Merz Investigational Site #420029
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Merz Investigational Site #420028
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Merz Investigational Site #420024
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czech Republic
Facility Name
Merz Investigational Site #420025
City
Pardubice
ZIP/Postal Code
53203
Country
Czech Republic
Facility Name
Merz Investigational Site #420030
City
Praha
ZIP/Postal Code
12000
Country
Czech Republic
Facility Name
Merz Investigational Site #420045
City
Praha
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Merz Investigational Site #420047
City
Rychnov nad Kneznou
ZIP/Postal Code
51601
Country
Czech Republic
Facility Name
Merz Investigational Site #049134
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Merz Investigational Site #036004
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Merz Investigational Site # 036009
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Merz Investigational Site #036005
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Merz Investigational Site #036008
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Merz Investigational Site #091003
City
Porur
State/Province
Chennai
ZIP/Postal Code
600116
Country
India
Facility Name
Merz Investigational Site #091006
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Merz Investigational Site #091002
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Merz Investigational Site #091007
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Facility Name
Merz Investigational Site #091008
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641014
Country
India
Facility Name
Merz Investigational Site #091001
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Merz Investigational Site #091004
City
New Delhi
ZIP/Postal Code
110065
Country
India
Facility Name
Merz Investigational Site # 048029
City
Gdansk
ZIP/Postal Code
80-254
Country
Poland
Facility Name
Merz Investigational Site #048044
City
Kielce
ZIP/Postal Code
25-103
Country
Poland
Facility Name
Merz Investigational Site #048031
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Merz Investigational Site #048050
City
Lodz
ZIP/Postal Code
90-130
Country
Poland
Facility Name
Merz Investigational Site #048051
City
Lublin
ZIP/Postal Code
20-022
Country
Poland
Facility Name
Merz Investigational Site #048032
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Merz Investigational Site #048053
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Merz Investigational Site #048023
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Merz Investigational Site #048052
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Merz Investigational Site #048033
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Merz Investigational Site #007010
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Merz Investigational Site #007011
City
Moscow
ZIP/Postal Code
105005
Country
Russian Federation
Facility Name
Merz Investigational Site #007009
City
St. Petersburg
ZIP/Postal Code
129019
Country
Russian Federation
Facility Name
Merz Investigational Site #007005
City
Stavropol
ZIP/Postal Code
355000
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
26201835
Citation
Elovic EP, Munin MC, Kanovsky P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity. Muscle Nerve. 2016 Mar;53(3):415-21. doi: 10.1002/mus.24776. Epub 2015 Dec 15. Erratum In: Muscle Nerve. 2016 Jun;54(1):170.
Results Reference
result
PubMed Identifier
31647185
Citation
Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. PM R. 2020 May;12(5):491-499. doi: 10.1002/pmrj.12265. Epub 2020 Jan 22. Erratum In: PM R. 2020 Jul;12(7):736.
Results Reference
derived
PubMed Identifier
30484117
Citation
Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study. Adv Ther. 2019 Jan;36(1):187-199. doi: 10.1007/s12325-018-0833-7. Epub 2018 Nov 27.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

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