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
NCT ID: NCT03992404
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
603 participants
INTERVENTIONAL
2019-09-16
2027-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NT 201 (IncobotulinumtoxinA, Xeomin)
Main Period (1 treatment cycle): subjects to receive intramuscular injection of NT 201 (400 units) into muscles of the lower limb.
Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.
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
Main Period (1 treatment cycle): subjects to receive intramuscular placebo injection into muscles of the lower limb.
Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
* Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
* Modified Ashworth Scale-Bohannon \[MAS\] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
* Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
* At least 4 months since last botulinum neurotoxin \[BoNT\] injection for treatment of spasticity or any other condition
* For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
* Activated partial thromboplastin time \[aPTT\] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
* International normalized ratio \[INR\] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
Exclusion Criteria
* Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
* Body weight \< 50 kg
* Severe atrophy of the target limb muscles
* Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
* Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: Surgical Intervention; Alcohol or phenol block; Muscle afferent block
* Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
* Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening
* Infection or inflammation at the injection sites
* Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
* Pregnancy (as verified by a positive pregnancy test) or breast feeding
18 Years
85 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals GmbH
Locations
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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
UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082
Dallas, Texas, United States
University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183
Houston, Texas, United States
Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237
Milwaukee, Wisconsin, United States
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
Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017
Novara, , Italy
Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022
Terracina, , Italy
Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077
Katowice, , Poland
Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059
Krakow, , Poland
NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101
Lodz, , Poland
Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096
Lublin, , Poland
Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100
Warsaw, , Poland
Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099
Warsaw, , Poland
Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023
Warsaw, , Poland
Mazowiecki Szpital Brodnowski, Merz investigational site #0480064
Warsaw, , Poland
Neuryt Diagnostyka I Terapia Neurologiczna, Merz investigational site #0480106
Wroclaw, , Poland
Federal State Budgetary Educational Institution of Higher Education "Krasnoyarsk State Medical University n.a. Professor V.F. Voino-Yasenetskiy of Ministry Healthcare of Russian Federation", Merz Investigational Site #0070306
Krasnoyarsk, , Russia
State Autonomous Institution of Healthcare of Moscow City "Moscow Scientific and Practical Centre of Medical Rehabilitation, Regenerative and Sports Medicine of Moscow City Healthcare Department", Merz Investigational Site #0070011
Moscow, , Russia
Federal State Autonomous Institution "National Medical Research Centre "Treatment and Rehabilitation" of the Ministry of Health of the Russian Federation, Neurology department, Merz Investigational Site # 0070305
Moscow, , Russia
Federal State Budgetary Institution "National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation, Merz Investigational Site #0070009
Saint Petersburg, , Russia
University Hospital Bratislav, 2nd Dept. of Neurology, Merz Investigational Site # 4210005
Bratislava, , Slovakia
Neurologicka klinika, Fakultna nemocnica Trnava; Merz investigational site #4210009
Trnava, , Slovakia
Hospital Universitario Juan Ramón Jiménez, Merz Investigational Site #0340037
Huelva, , Spain
Hospital Universitario La Paz, Merz Investigational Site #0340007
Madrid, , Spain
Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003
Terrassa, , Spain
University Hospital of Bern, Center of Parkinson's diseases and Movement disorders (ZfPB), Merz investigational site #0410015
Bern, , Switzerland
HFR Fribourg - Hôpital Cantonal, Department of Rehabilitation, Merz Investigational site #0410014
Meyriez, , Switzerland
CRR, Mee Suva (Clinique romande de réadaptation), Merz investigational site #0410016
Sion, , Switzerland
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron", Merz Investigational Site #3800018
Kharkiv, , Ukraine
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine; Merz Investigational Site #3800019
Kharkiv, , Ukraine
Lviv regional clinical hospital; Merz investigational site # 3800020
Lviv, , Ukraine
Rivne City Hospital 2, Department of Clinical Neurology and Neurorehabilitation; Merz investigational site #3800016
Rivne, , Ukraine
NPE "Regional Clinical Centre of Neurosurgery and Neurology" Transcarpathian Regional Council; Merz investigational site #3800014
Uzhhorod, , Ukraine
Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023
Cambridge, , United Kingdom
Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047
Exeter, , United Kingdom
The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004
Liverpool, , United Kingdom
Countries
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Other Identifiers
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2018-001639-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M602011014
Identifier Type: -
Identifier Source: org_study_id