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Can botox ease leg stiffness after stroke? new trial investigates

NCT ID NCT03992404

Symptom relief Sponsor: Merz Pharmaceuticals GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tests whether a single injection of botulinum toxin (NT 201) can reduce leg muscle stiffness caused by stroke or traumatic brain injury in adults. About 600 participants will be randomly assigned to receive either the treatment or a placebo, and neither they nor their doctors will know which they got. The main goal is to see if the treatment improves muscle tightness and overall function better than no treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

603 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lower limb or combined lower limb and upper limb spasticity due to stroke or traumatic brain injury

Contacts and locations

Locations

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

    Foggia, 71122, Italy

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

    Jacksonville, Florida, 72204, United States

  • CHU Brugmann Neurology; Merz investigational site #0320015

    Brussels, 1020, Belgium

  • CHU Lille/Hôpital Swynghedauw; investigational site # 0330045

    Lille, 59000, France

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

    Sion, 1950, Switzerland

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

    Cambridge, CB2 0QQ, United Kingdom

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

    Wiesbaden, 65191, Germany

  • 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, 125367, Russia

  • 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, 660049, 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, 195119, Russia

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

    Warsaw, 01-518, Poland

  • Glenrose Rehabilitation Hospital, Merz investigational site #0010195

    Edmonton, T5G 0B7, Canada

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

    Meyriez, 3280, Switzerland

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

    Düsseldorf, 40225, Germany

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

    Terrassa, 08221, Spain

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

    Huelva, 21005, Spain

  • Hospital Universitario La Paz, Merz Investigational Site #0340007

    Madrid, 28046, Spain

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

    Columbia, Missouri, 65203, United States

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

    Genova, 16132, Italy

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

    New York, New York, 10029, United States

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

    Lublin, 20-582, Poland

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

    Strasbourg, 67000, France

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

    Kharkiv, 61000, Ukraine

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

    Kharkiv, 61000, Ukraine

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

    Warsaw, 02-957, Poland

  • Lviv regional clinical hospital; Merz investigational site # 3800020

    Lviv, 79010, Ukraine

  • Mazowiecki Szpital Brodnowski, Merz investigational site #0480064

    Warsaw, 03-242, Poland

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

    Milwaukee, Wisconsin, 53226, United States

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

    Uzhhorod, 88018, Ukraine

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

    Lodz, 90-640, Poland

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

    Trnava, 917 01, Slovakia

  • Neurologie Bewegt; Merz Investigational site #0490378

    Berlin, 10627, Germany

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

    Würzburg, 97080, Germany

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

    Foxborough, Massachusetts, 02035, United States

  • Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049

    Brno, 61500, Czechia

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

    Wroclaw, 50-305, Poland

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

    Stamford, Connecticut, 06905, United States

  • Nova Clinical Research, Merz investigational site #0010474

    Brandenton, Florida, 34209, United States

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

    Terracina, 04019, Italy

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

    Novara, 28100, Italy

  • Pardubice Regional Hospital; Merz investigational site #4200025

    Pardubice, 530 03, Czechia

  • Petz Hospital, Neurology, Merz Investigational Site #0360010

    Győr, 9024, Hungary

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

    Birmingham, Alabama, 35233, United States

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

    Warsaw, 02-121, Poland

  • Pôle Saint-Hélier; Merz investigational site #0330024

    Rennes, 35000, France

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

    Downey, California, 90242, United States

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

    Toulouse, 31059, France

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

    Garches, 92380, France

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

    Rivne, 33001, Ukraine

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

    Exeter, EX2 5DW, United Kingdom

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

    Sarasota, Florida, 34239, United States

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

    Katowice, 40-097, Poland

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

    Krakow, 30-539, Poland

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

    Kisvárda, 4600, Hungary

  • 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, 105005, Russia

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

    Liverpool, L9 7LJ, United Kingdom

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

    Brussels, 1200, Belgium

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

    Yvoir, 5530, Belgium

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

    Dallas, Texas, 75390-9055, United States

  • UZ Leuven Pellenberg campus; Merz investigational site #0320014

    Pellenberg, 3212, Belgium

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

    Aachen, 52074, Germany

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

    Bratislava, 83305, Slovakia

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

    Ostrava, 708 52, Czechia

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

    Bern, 3010, Switzerland

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

    Little Rock, Arkansas, 72205, United States

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

    Bonn, 53127, Germany

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

    Pittsburgh, Pennsylvania, 15213, United States

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

    Szeged, 6725, Hungary

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

    Houston, Texas, 77030, United States

  • Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079

    Hamburg, 20246, Germany

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

    New York, New York, 10065, United States