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

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ClinicalTrials.gov Identifier: NCT01464307
Recruitment Status : Completed
First Posted : November 3, 2011
Results First Posted : November 6, 2016
Last Update Posted : November 6, 2016
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Tracking Information
First Submitted Date  ICMJE November 1, 2011
First Posted Date  ICMJE November 3, 2011
Results First Submitted Date  ICMJE July 26, 2016
Results First Posted Date  ICMJE November 6, 2016
Last Update Posted Date November 6, 2016
Study Start Date  ICMJE December 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4 [ Time Frame: Baseline and Week 4 ]
    The AS 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).
  • Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12 [ Time Frame: Baseline to Week 12 ]
    A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
  • Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4 [ Time Frame: Baseline to week 4 ]
    The AS 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).
  • Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12 [ Time Frame: Baseline to Week 12 ]
    A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post markting commitments for U.S. regulatory authorities only. Elswhere, it will be a secondary outcome measure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS) [ Time Frame: Week 4, 8, and 12 ]
    Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS 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).
  • Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits [ Time Frame: Baseline, Week 4, 8, and 12 ]
    The AS 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). Here, 'n' specifies those subjects who were evaluated for this outcome measure at given time point.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
  • Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS) [ Time Frame: Week 4, 8, and 12 ]
    The AS 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).
  • Change from baseline in Ashworth Scale (AS) for plantar flexors at all post-baseline visits [ Time Frame: From baseline up to week 12 ]
    The AS 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
Official Title  ICMJE 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 Lower Limb
Brief Summary The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-stroke Spasticity of the Lower Limb
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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 Arm
    Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
    Intervention: Drug: Placebo Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2016)
290
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2011)
328
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age from 18-80 yrs
  • Lower 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 lower limb
  • Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
  • Infection at the injection site
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czech Republic,   France,   Germany,   Italy,   Poland,   Russian Federation,   Spain,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT01464307
Other Study ID Numbers  ICMJE MRZ 60201/SP/3002
2010-024579-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz Pharmaceuticals GmbH
Study Sponsor  ICMJE Merz Pharmaceuticals GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Expert Merz Pharmaceuticals GmbH
PRS Account Merz Pharmaceuticals GmbH
Verification Date September 2016

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