Trial record 1 of 1 for:    MRZ 60201/SP/3002
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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)

This study is currently recruiting participants.
Verified March 2014 by Merz Pharmaceuticals GmbH
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01464307
First received: November 1, 2011
Last updated: March 18, 2014
Last verified: March 2014

November 1, 2011
March 18, 2014
December 2011
October 2014   (final data collection date for primary outcome measure)
  • Change from baseline in Ashworth Scale (AS) for plantar flexors at Week 4 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.

Same as current
Complete list of historical versions of study NCT01464307 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.

Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg 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 Lower Limb

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-stroke Spasticity of the Lower 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.
  • 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 Arm
    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.
 
Recruiting
328
August 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Public Disclosure Manager clinicaltrials@merz.de
United States,   Austria,   Canada,   Czech Republic,   France,   Germany,   Italy,   Poland,   Russian Federation,   Spain
 
NCT01464307
MRZ 60201/SP/3002, 2010-024579-23
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