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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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