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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Spasticity of the Upper Limb
• Intervention / Treatment: Drug: IncobotulinumtoxinA (400 Units); Drug: Placebo Comparator

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).

• Study Type: Interventional
• Enrollment (Actual): 317
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Brno, Czech Republic, 62500
    • Merz Investigational Site #420046
  • Brno, Czech Republic, 65691
    • Merz Investigational Site #420029
  • Olomouc, Czech Republic, 77520
    • Merz Investigational Site #420028
  • Ostrava-Poruba, Czech Republic, 70852
    • Merz Investigational Site #420024
  • Pardubice, Czech Republic, 53203
    • Merz Investigational Site #420025
  • Praha, Czech Republic, 12000
    • Merz Investigational Site #420030
  • Praha, Czech Republic, 15006
    • Merz Investigational Site #420045
  • Rychnov nad Kneznou, Czech Republic, 51601
    • Merz Investigational Site #420047
• Germany
  • Rostock, Germany, 18147
    • Merz Investigational Site #049134
• Hungary
  • Budapest, Hungary, 1121
    • Merz Investigational Site #036004
  • Budapest, Hungary, 1204
    • Merz Investigational Site # 036009
  • Nyiregyhaza, Hungary, 4400
    • Merz Investigational Site #036005
  • Szeged, Hungary, 6725
    • Merz Investigational Site #036008
• India
  • New Delhi, India, 110065
    • Merz Investigational Site #091004
  • Chennai
    • Porur, Chennai, India, 600116
      • Merz Investigational Site #091003
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • Merz Investigational Site #091006
  • Kerala
    • Trivandrum, Kerala, India, 695011
      • Merz Investigational Site #091002
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600116
      • Merz Investigational Site #091007
    • Coimbatore, Tamil Nadu, India, 641014
      • Merz Investigational Site #091008
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • Merz Investigational Site #091001
• Poland
  • Gdansk, Poland, 80-254
    • Merz Investigational Site # 048029
  • Kielce, Poland, 25-103
    • Merz Investigational Site #048044
  • Krakow, Poland, 31-505
    • Merz Investigational Site #048031
  • Lodz, Poland, 90-130
    • Merz Investigational Site #048050
  • Lublin, Poland, 20-022
    • Merz Investigational Site #048051
  • Olsztyn, Poland, 10-561
    • Merz Investigational Site #048032
  • Poznan, Poland, 61-485
    • Merz Investigational Site #048053
  • Warszawa, Poland, 02-957
    • Merz Investigational Site #048023
  • Warszawa, Poland, 04-141
    • Merz Investigational Site #048052
  • Warszawa, Poland, 04-749
    • Merz Investigational Site #048033
• Russian Federation
  • Krasnoyarsk, Russian Federation, 660037
    • Merz Investigational Site #007010
  • Moscow, Russian Federation, 105005
    • Merz Investigational Site #007011
  • St. Petersburg, Russian Federation, 129019
    • Merz Investigational Site #007009
  • Stavropol, Russian Federation, 355000
    • Merz Investigational Site #007005
• United States
  • California
    • Downey, California, United States, 90242
      • Merz Investigational Site #001184
    • Fountain Valley, California, United States, 92728
      • Merz Investigational Site #001017
  • Florida
    • Miami, Florida, United States, 33172
      • Merz Investigational Site #001188
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Merz Investigational Site #001037
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Merz Investigational Site #001186
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Merz Investigational Site # 001110
  • New Jersey
    • Stratford, New Jersey, United States, 08084
      • Merz Investigational Site #001198
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Merz Investigational Site #001240
    • Winston-Salem, North Carolina, United States, 27157
      • Merz Investigational Site #001009
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Merz Investigational Site #001241
    • Pittsburgh, Pennsylvania, United States, 15213
      • Merz Investigational Site #001211
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Merz Investigational Site #001245
  • Texas
    • Houston, Texas, United States, 77030
      • Merz Investigational Site #001226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DB IncobotulinumtoxinA (Xeomin) (400 U); IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment	Drug: 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; Other Names: Xeomin
PLACEBO_COMPARATOR: DB Placebo Comparator; Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 4
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.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 4
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.	Week 8
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.	Week 12
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.	Week 4
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.	Week 8
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.	Week 12
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.	Week 4
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.	Week 8
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.	Week 12
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.	Week 4
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.	Week 8
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.	Week 12
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.	Week 4
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.	Week 8
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.	Week 12
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.	Week 4
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.	Week 8
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.	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12
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).	Week 4
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).	Week 8
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).	Week 12

Collaborators and Investigators

• Sponsor: Merz Pharmaceuticals GmbH

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (ESTIMATE): July 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: MRZ 60201/SP/3001; 2010-023043-15 (EUDRACT_NUMBER)