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ACTIVE NOT RECRUITING

NCT03992404

PHASE3

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

Sponsor: Merz Pharmaceuticals GmbH

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension With or Without Combined Upper Limb Treatment

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

603

Start Date

2019-09-16

Completion Date

2027-04

Last Updated

2026-03-20

Healthy Volunteers

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).

Inclusion Criteria: * Female or male subject ≥ 18 years and ≤ 85 years at screening * 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: * Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study * 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

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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)