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 7, 2016
Last Update Posted
: November 7, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | November 1, 2011 | |||
First Posted Date ICMJE | November 3, 2011 | |||
Results First Submitted Date | July 26, 2016 | |||
Results First Posted Date | November 7, 2016 | |||
Last Update Posted Date | November 7, 2016 | |||
Study Start Date ICMJE | December 2011 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01464307 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Post-stroke Spasticity of the Lower Limb | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
290 | |||
Original Estimated Enrollment ICMJE |
328 | |||
Actual Study Completion Date | May 2015 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Czech Republic, France, Germany, Italy, Poland, Russian Federation, Spain, United States | |||
Removed Location Countries | Austria | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01464307 | |||
Other Study ID Numbers ICMJE | MRZ 60201/SP/3002 2010-024579-23 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Merz Pharmaceuticals GmbH | |||
Study Sponsor ICMJE | Merz Pharmaceuticals GmbH | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Merz Pharmaceuticals GmbH | |||
Verification Date | September 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |