NT 201: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Placebo: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479 | Birmingham | Alabama | |
| University of Arkansas for Medical Sciences, Merz investigational site #0010481 | Little Rock | Arkansas | |
| Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184 | Downey | California | |
| New England institute for clinical research; Merz Investigational Site #0010441 | Stamford | Connecticut | |
| Nova Clinical Research, Merz investigational site #0010474 | Brandenton | Florida | |
| Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483 | Jacksonville | Florida | |
| Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478 | Sarasota | Florida | |
| Neurology Center of New England P.C., Merz investigative site #0010476 | Foxborough | Massachusetts | |
| Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283 | Columbia | Missouri | |
| Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191 | New York | New York | |
| Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440 | New York | New York | |
| University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211 | Pittsburgh | Pennsylvania | |
| UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082 | Dallas | Texas | |
| University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183 | Houston | Texas | |
| Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237 | Milwaukee | Wisconsin | |
| CHU Brugmann Neurology; Merz investigational site #0320015 | Brussels | Belgium | |
| UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013 | Brussels | Belgium | |
| UZ Leuven Pellenberg campus; Merz investigational site #0320014 | Pellenberg | Belgium | |
| UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008 | Yvoir | Belgium | |
| Glenrose Rehabilitation Hospital, Merz investigational site #0010195 | Edmonton | Canada | |
| Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049 | Brno | Czechia | |
| University Hospital Ostrava; Neurology Departement, Merz investigational site #4200024 | Ostrava | Czechia | |
| Pardubice Regional Hospital; Merz investigational site #4200025 | Pardubice | Czechia | |
| Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation, Merz Investigational site #00330018 | Garches | France | |
| CHU Lille/Hôpital Swynghedauw; investigational site # 0330045 | Lille | France | |
| Pôle Saint-Hélier; Merz investigational site #0330024 | Rennes | France | |
| Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063 | Strasbourg | France | |
| Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Médecine physique et de réadaptation, Merz investigational site #0330025 | Toulouse | France | |
| Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191 | Aachen | Germany | |
| Neurologie Bewegt; Merz Investigational site #0490378 | Berlin | Germany | |
| University of Bonn Medical Center, Department of Neurodegenerative disease, Merz investigational site #0490390 | Bonn | Germany | |
| Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071 | Düsseldorf | Germany | |
| Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079 | Hamburg | Germany | |
| DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081 | Wiesbaden | Germany | |
| Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302 | Würzburg | Germany | |
| Petz Hospital, Neurology, Merz Investigational Site #0360010 | Győr | Hungary | |
| St.Damjan Hospital, Kisvarda; Merz investigational site #0360019 | Kisvárda | Hungary | |
| University of Szeged, Department of Neurology, Merz investigational site #0360008 | Szeged | Hungary | |
| Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018 | Foggia | Italy | |
| IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020 | Genova | Italy |
+ 31 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03992404 on ClinicalTrials.gov ↗ ← All trials in the UK