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Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Condition: Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury · Sponsor: Merz Pharmaceuticals GmbH
About this study
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (71)
| Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479 | Birmingham, Alabama, United States | — |
| University of Arkansas for Medical Sciences, Merz investigational site #0010481 | Little Rock, Arkansas, United States | — |
| Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184 | Downey, California, United States | — |
| New England institute for clinical research; Merz Investigational Site #0010441 | Stamford, Connecticut, United States | — |
| Nova Clinical Research, Merz investigational site #0010474 | Brandenton, Florida, United States | — |
| Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483 | Jacksonville, Florida, United States | — |
| Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478 | Sarasota, Florida, United States | — |
| Neurology Center of New England P.C., Merz investigative site #0010476 | Foxborough, Massachusetts, United States | — |
| Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283 | Columbia, Missouri, United States | — |
| Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191 | New York, New York, United States | — |
| Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440 | New York, New York, United States | — |
| University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211 | Pittsburgh, Pennsylvania, United States | — |
+ 59 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03992404