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Completed

NCT Number: NCT01392300

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

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.

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Key information

Conditions

Post-stroke Spasticity of the Upper Limb

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Merz Investigational Site #420029, Brno, Czechia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IncobotulinumtoxinA (400 Units)

Drug

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

Drug

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 outcomes

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

    Time frame: Week 4

    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).

  2. Investigator's Global Impression of Change

    Time frame: Week 4

    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 outcomes

  1. Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern

    Time frame: Week 4

    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.

  2. Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern

    Time frame: Week 8

    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.

  3. Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern

    Time frame: Week 12

    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.

  4. Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist

    Time frame: Week 4

    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.

  5. Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist

    Time frame: Week 8

    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.

  6. Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist

    Time frame: Week 12

    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.

  7. Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow

    Time frame: Week 4

    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.

  8. Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow

    Time frame: Week 8

    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.

  9. Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow

    Time frame: Week 12

    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.

  10. Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist

    Time frame: Week 4

    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.

  11. Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist

    Time frame: Week 8

    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.

  12. Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist

    Time frame: Week 12

    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.

  13. Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm

    Time frame: Week 4

    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.

  14. Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm

    Time frame: Week 8

    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.

  15. Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm

    Time frame: Week 12

    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.

  16. Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm

    Time frame: Week 4

    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.

  17. Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm

    Time frame: Week 8

    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.

  18. Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm

    Time frame: Week 12

    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.

  19. Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.

    Time frame: Week 4

    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).

  20. Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.

    Time frame: Week 8

    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).

  21. Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.

    Time frame: Week 12

    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).

  22. Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.

    Time frame: Week 4

    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).

  23. Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.

    Time frame: Week 8

    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).

  24. Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.

    Time frame: Week 12

    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).

  25. Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.

    Time frame: Week 4

    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).

  26. Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.

    Time frame: Week 8

    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).

  27. Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.

    Time frame: Week 12

    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).

  28. Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.

    Time frame: Week 4

    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).

  29. Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.

    Time frame: Week 8

    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).

  30. Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.

    Time frame: Week 12

    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).

  31. Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.

    Time frame: Week 4

    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).

  32. Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.

    Time frame: Week 8

    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).

  33. Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.

    Time frame: Week 12

    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).

  34. Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain

    Time frame: Week 4

    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).

  35. Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain

    Time frame: Week 8

    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).

  36. Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain

    Time frame: Week 12

    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).

  37. Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene

    Time frame: Week 4

    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).

  38. Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene

    Time frame: Week 8

    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).

  39. Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene

    Time frame: Week 12

    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).

  40. Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing

    Time frame: Week 4

    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).

  41. Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing

    Time frame: Week 8

    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).

  42. Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing

    Time frame: Week 12

    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).

  43. Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position

    Time frame: Week 4

    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).

  44. Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position

    Time frame: Week 8

    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).

  45. Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position

    Time frame: Week 12

    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).

  46. Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain

    Time frame: Week 4

    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).

  47. Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain

    Time frame: Week 8

    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).

  48. Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain

    Time frame: Week 12

    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).

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study 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

Acronym: PURE

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 12, 2011
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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