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

November 4, 2016 updated by: Merz Pharmaceuticals GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Winnipeg, Canada, MB R3A 1M4
        • Merz Investigational Site #001202
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
        • Merz Investigational Site #001204
  • Czech Republic
      • Ostrava-Poruba, Czech Republic, 70852
        • Merz Investigational Site #420024
      • Ostrava-Vitkovice, Czech Republic, 70384
        • Merz Investigational Site #420031
      • Praha, Czech Republic, 12000
        • Merz Investigational Site #420030
      • Rychnov nad Kneznou, Czech Republic, 51601
        • Merz Investigational Site #420047
  • France
      • Garches, France, 92380
        • Merz Investigational Site #033018
      • Rennes, France, 35043
        • Merz Investigational Site #033024
  • Germany
      • Beelitz-Heilstätten, Germany, 14547
        • Merz Investigational Site #049022
      • Düsseldorf, Germany, 40225
        • Merz Investigational Site #049071
      • Hamburg, Germany, 20246
        • Merz Investigational Site #049079
      • Kiel, Germany, 24105
        • Merz Investigational Site #049304
      • München, Germany, 80804
        • Merz Investigational Site #049072
      • München, Germany, 81675
        • Merz Investigational Site #049148
      • Regensburg, Germany, 93053
        • Merz Investigational Site #049303
      • Würzburg, Germany, 97080
        • Merz Investigational Site #049302
  • Italy
      • Messina, Italy, 98125
        • Merz Investigational Site #039006
      • Roma, Italy, 00168
        • Merz Investigational Site #039011
      • Roma, Italy, 00189
        • Merz Investigational Site #039012
  • Poland
      • Gdansk, Poland, 80-462
        • Merz Investigational Site #048057
      • Kielce, Poland, 25-103
        • Merz Investigational Site #048044
      • Krakow, Poland, 31-505
        • Merz Investigational Site #048031
      • Krakow, Poland, 30-349
        • Merz Investigational Site #048080
      • Krakow, Poland, 30-510
        • Merz Investigational Site #048054
      • Lodz, Poland, 90-130
        • Merz Investigational Site #048022
      • Lublin, Poland, 20-022
        • Merz Investigational Site #048051
      • Poznan, Poland, 61-485
        • Merz Investigational Site #048053
      • Poznan, Poland, 61-853
        • Merz Investigational Site #048081
      • Warszawa, Poland, 02-957
        • Merz Investigational Site #048023
      • Warszawa, Poland, 04-749
        • Merz Investigational Site #048033
      • Warszawa, Poland, 01-697
        • Merz Investigational Site #048055
      • Warszawa, Poland, 02097
        • Merz Investigational Site #048056
  • 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 #007012
  • Spain
      • Madrid, Spain, 28040
        • Merz Investigational Site #034027
      • Majadahonda, Spain, 28222
        • Merz Investigational Site #034028
      • Sevilla, Spain, 41013
        • Merz Investigational Site #034030
      • Sevilla, Spain, 41009
        • Merz Investigational Site #034026
      • Terrassa, Spain, 08221
        • Merz Investigational Site #034029
  • United States
    • California
      • Downey, California, United States, 90242
        • Merz Investigational Site #001184
      • Long Beach, California, United States, 90806
        • Merz Investigational Site #001208
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Merz Investigational Site #001244
    • Florida
      • Doral, Florida, United States, 33172
        • Investigational site #001188
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Merz Investigational Site # 001110
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Merz Investigational Site #001209
      • St. Louis, Missouri, United States, 63110
        • Merz Investigational Site #001210
    • New Jersey
      • Stratford, New Jersey, United States, 08084
        • Merz Investigational Site #001198
    • New York
      • Plainview, New York, United States, 11803
        • Merz Investigational Site #001207
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Merz Investigational Site #001009
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Merz Investigational Site #001206
    • Texas
      • Houston, Texas, United States, 77030
        • Merz Investigational Site #001183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Placebo Comparator: Placebo Comparator Arm
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and Week 4
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.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 4, 8, and 12
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.
Baseline, Week 4, 8, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz Pharmaceuticals GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRZ 60201/SP/3002
  • 2010-024579-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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