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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

603

Participants

Timeline

Start Date

September 16, 2019

Primary Completion Date

June 19, 2025

Study Completion Date

April 30, 2027

Conditions
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Interventions
DRUG

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).

DRUG

Placebo

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Trial Locations (71)

1020

CHU Brugmann Neurology; Merz investigational site #0320015, Brussels

1200

UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013, Brussels

1950

CRR, Mee Suva (Clinique romande de réadaptation), Merz investigational site #0410016, Sion

3010

University Hospital of Bern, Center of Parkinson's diseases and Movement disorders (ZfPB), Merz investigational site #0410015, Bern

3212

UZ Leuven Pellenberg campus; Merz investigational site #0320014, Pellenberg

3280

HFR Fribourg - Hôpital Cantonal, Department of Rehabilitation, Merz Investigational site #0410014, Meyriez

4600

St.Damjan Hospital, Kisvarda; Merz investigational site #0360019, Kisvárda

5530

UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008, Yvoir

6725

University of Szeged, Department of Neurology, Merz investigational site #0360008, Szeged

9024

Petz Hospital, Neurology, Merz Investigational Site #0360010, Győr

10029

Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191, New York

10065

Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440, New York

10627

Neurologie Bewegt; Merz Investigational site #0490378, Berlin

15213

University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211, Pittsburgh

16132

IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020, Genova

20246

Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079, Hamburg

21005

Hospital Universitario Juan Ramón Jiménez, Merz Investigational Site #0340037, Huelva

28046

Hospital Universitario La Paz, Merz Investigational Site #0340007, Madrid

28100

Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017, Novara

31059

Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Médecine physique et de réadaptation, Merz investigational site #0330025, Toulouse

33001

Rivne City Hospital 2, Department of Clinical Neurology and Neurorehabilitation; Merz investigational site #3800016, Rivne

34209

Nova Clinical Research, Merz investigational site #0010474, Brandenton

34239

Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478, Sarasota

35000

Pôle Saint-Hélier; Merz investigational site #0330024, Rennes

35233

Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479, Birmingham

40225

Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071, Düsseldorf

52074

Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191, Aachen

53127

University of Bonn Medical Center, Department of Neurodegenerative disease, Merz investigational site #0490390, Bonn

53226

Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237, Milwaukee

59000

CHU Lille/Hôpital Swynghedauw; investigational site # 0330045, Lille

61000

"Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, MC Neuron, Merz Investigational Site #3800018", Kharkiv

Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine; Merz Investigational Site #3800019, Kharkiv

61500

Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049, Brno

65191

DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081, Wiesbaden

65203

Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283, Columbia

67000

Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063, Strasbourg

71122

Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018, Foggia

72204

Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483, Jacksonville

72205

University of Arkansas for Medical Sciences, Merz investigational site #0010481, Little Rock

77030

University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183, Houston

79010

Lviv regional clinical hospital; Merz investigational site # 3800020, Lviv

83305

University Hospital Bratislav, 2nd Dept. of Neurology, Merz Investigational Site # 4210005, Bratislava

88018

"NPE Regional Clinical Centre of Neurosurgery and Neurology Transcarpathian Regional Council; Merz investigational site #3800014", Uzhhorod

90242

Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184, Downey

92380

Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation, Merz Investigational site #00330018, Garches

97080

Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302, Würzburg

105005

"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

125367

"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

195119

"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

660049

"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

06905

New England institute for clinical research; Merz Investigational Site #0010441, Stamford

02035

Neurology Center of New England P.C., Merz investigative site #0010476, Foxborough

75390-9055

UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082, Dallas

T5G 0B7

Glenrose Rehabilitation Hospital, Merz investigational site #0010195, Edmonton

708 52

University Hospital Ostrava; Neurology Departement, Merz investigational site #4200024, Ostrava

530 03

Pardubice Regional Hospital; Merz investigational site #4200025, Pardubice

04019

Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022, Terracina

40-097

Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077, Katowice

30-539

Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059, Krakow

90-640

NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101, Lodz

20-582

Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096, Lublin

01-518

Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100, Warsaw

02-121

Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099, Warsaw

02-957

Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023, Warsaw

03-242

Mazowiecki Szpital Brodnowski, Merz investigational site #0480064, Warsaw

50-305

Neuryt Diagnostyka I Terapia Neurologiczna, Merz investigational site #0480106, Wroclaw

917 01

Neurologicka klinika, Fakultna nemocnica Trnava; Merz investigational site #4210009, Trnava

08221

Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003, Terrassa

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023, Cambridge

EX2 5DW

Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047, Exeter

L9 7LJ

The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004, Liverpool

Sponsors
All Listed Sponsors
lead

Merz Pharmaceuticals GmbH

INDUSTRY

NCT03992404 - 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 | Biotech Hunter | Biotech Hunter