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
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (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 |
Enrollment | 290 |
Recruitment Details | 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 One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication.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 | 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 One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication.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. |
Arm/Group Title | IncobotulinumtoxinA (Xeomin) 400 Units | Placebo |
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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 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 |
Period Title: Main Period | ||
Started | 144 | 145 |
Treated | 144 | 145 |
Completed | 129 | 140 |
Not Completed | 15 | 5 |
Reason Not Completed | ||
Death | 0 | 1 |
Adverse Event | 6 | 1 |
Lack of Efficacy | 2 | 0 |
Withdrawal by Subject | 5 | 2 |
Predefined discontinuation criteria | 2 | 1 |
Period Title: Open-Label Extension Period | ||
Started | 269 | 0 |
Treated | 269 | 0 |
Completed | 218 | 0 |
Not Completed | 51 | 0 |
Reason Not Completed | ||
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 |
Arm/Group Title | Main Period: IncobotulinumtoxinA (Xeomin) 400 Units | Main Period: Placebo | Total | |
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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. |
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 of all reporting groups | |
Overall Number of Baseline Participants | 144 | 145 | 289 | |
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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.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 144 participants | 145 participants | 289 participants | |
57.3 (11.2) | 57.0 (13.0) | 57.2 (12.1) | ||
Gender
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 144 participants | 145 participants | 289 participants | |
Female |
40 27.8%
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55 37.9%
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95 32.9%
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Male |
104 72.2%
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90 62.1%
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194 67.1%
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Name/Title: | Public Disclosure Manager |
Organization: | Merz Pharmaceuticals GmbH |
Phone: | +49 69 1503 1 |
EMail: | clinicaltrials@merz.de |
Responsible Party: | Merz Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT01464307 |
Other Study ID Numbers: |
MRZ 60201/SP/3002 2010-024579-23 ( EudraCT Number ) |
First Submitted: | November 1, 2011 |
First Posted: | November 3, 2011 |
Results First Submitted: | July 26, 2016 |
Results First Posted: | November 6, 2016 |
Last Update Posted: | November 6, 2016 |