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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01464307
First received: November 1, 2011
Last updated: November 4, 2016
Last verified: September 2016
History of Changes
Results First Received: July 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Post-stroke Spasticity of the Lower Limb
Interventions: Drug: IncobotulinumtoxinA (400 Units)
Drug: Placebo Comparator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 331 individuals suffering from post-stroke lower-limb spasticity were screened and 290 were included in study at 51 sites. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. For purpose of study analysis overall number of subjects enrolled is therefore considered 289.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 290 subjects were enrolled in study. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. A total of 289 subjects were enrolled in main period. All of the 269 subjects who completed the main period of the study entered the open-label extension period.

Reporting Groups
  Description
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.

IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl), 400 units, total volume 8.0 milliliter (mL); Mode of administration: intramuscular injection.

IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection sessions of solution, prepared by reconstitution of powder with 0.9% NaCl, 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.
Placebo

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

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

Participant Flow for 2 periods

 Period 1:   Main Period
    IncobotulinumtoxinA (Xeomin) 400 Units   Placebo
STARTED   144   145 
Treated   144   145 
COMPLETED   129   140 
NOT COMPLETED   15   5 
Death                0                1 
Adverse Event                6                1 
Lack of Efficacy                2                0 
Withdrawal by Subject                5                2 
Predefined discontinuation criteria                2                1 

Period 2:   Open-Label Extension Period
    IncobotulinumtoxinA (Xeomin) 400 Units   Placebo
STARTED   269   0 
Treated   269   0 
COMPLETED   218   0 
NOT COMPLETED   51   0 
Adverse Event                15                0 
Withdrawal by Subject                14                0 
Lack of Efficacy                5                0 
Death                1                0 
Lost to Follow-up                1                0 
Non-compliance                9                0 
Predefined discontinuation criteria                6                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety Evaluation Set (SES) is the subset of all subjects who were exposed to Investigational product (IP) in the main period at least once.

Reporting Groups
  Description
Main Period: 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.

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.
Main Period: Placebo

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

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
Total Total of all reporting groups

Baseline Measures
   Main Period: IncobotulinumtoxinA (Xeomin) 400 Units   Main Period: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 144   145   289 
Age 
[Units: Years]
Mean (Standard Deviation) 		 57.3  (11.2)   57.0  (13.0)   57.2  (12.1) 
Gender 
[Units: Participants]
Count of Participants 		     
Female      40  27.8%      55  37.9%      95  32.9% 
Male      104  72.2%      90  62.1%      194  67.1% 


  Outcome Measures
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1.  Primary:   Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 1

2.  Primary:   Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12   [ Time Frame: Baseline to Week 12 ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  Secondary:   Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits   [ Time Frame: Baseline, Week 4, 8, and 12 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals GmbH
phone: +49 69 1503 1
e-mail: clinicaltrials@merz.de



Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01464307     History of Changes
Other Study ID Numbers: MRZ 60201/SP/3002
2010-024579-23 ( EudraCT Number )
Study First Received: November 1, 2011
Results First Received: July 26, 2016
Last Updated: November 4, 2016