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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01392300
First received: July 7, 2011
Last updated: March 19, 2014
Last verified: March 2014

July 7, 2011
March 19, 2014
September 2011
March 2013   (final data collection date for primary outcome measure)
  • Change from baseline in Ashworth Scale (AS) Score of primary target clinical pattern [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    Primary target clinical pattern is defined by investigator for each subject at baseline visit and will be 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). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

  • Investigator's Global Impression of Change [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    This is a 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.
Change from baseline in Ashworth Scale (AS) of wrist flexors [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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 primary efficacy analysis.
Complete list of historical versions of study NCT01392300 on ClinicalTrials.gov Archive Site
  • Response rates in each treated muscle group (elbow, wrist, and finger flexors as well as thumb muscles and forearm pronators) at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the AS. [ Time Frame: Baseline up to week 48 ] [ Designated as safety issue: No ]
    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 all post-baseline visits in Ashworth Scale Score for each treated muscle group. [ Time Frame: Baseline up to week 48 ] [ Designated as safety issue: No ]
    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 all post-baseline visits in Disability Assessment Scale (primary therapeutic target and additionally all 4 items regardless of chosen primary therapeutic target) [ Time Frame: Baseline up to week 48 ] [ Designated as safety issue: No ]
    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).
  • Response rates for the primary target clinical pattern for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the Ashworth Scale [ Time Frame: Baseline up to week 48 ] [ Designated as safety issue: No ]
    Primary target clinical pattern is defined by investigator for each subject at baseline visit and will be either flexed wrist or clenched fist or flexed elbow.
  • Response rates in each treated muscle group (elbow, wrist, and finger flexors as well as thumb muscles and forearm pronators) at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the AS. [ Time Frame: Week 4, week 8, week 12. ] [ Designated as safety issue: No ]
    The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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 primary efficacy analysis.
  • AS for each treated muscle group at all visits and changes from baseline at all post-baseline visits [ Time Frame: Baseline to week 4, week 8, week 12 ] [ Designated as safety issue: No ]
    The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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 primary efficacy analysis.
  • Disability Assessment Scale (DAS): (primary therapeutic target and additionally all 4 items regardless of chosen primary therapeutic target) at all visits and changes from baseline at all post-baseline visits. [ Time Frame: Baseline to week 4, week 8, week 12. ] [ Designated as safety issue: No ]
    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).
Not Provided
Not Provided
 
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Post-stroke Spasticity of the Upper Limb.
  • 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 Name: Xeomin
  • 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
  • Experimental: IncobotulinumtoxinA (Xeomin) (400 Units)
    IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
    Intervention: Drug: IncobotulinumtoxinA (400 Units)
  • Placebo Comparator: Placebo Comparator
    Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
February 2014
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Germany,   Hungary,   India,   Poland,   Russian Federation
 
NCT01392300
MRZ 60201/SP/3001, 2010-023043-15
Yes
Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
Not Provided
Study Director: Medical Expert Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP