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Clinical Trials in the UK / NCT03992404
Active, not recruiting Phase 3

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

NCT03992404 · tracked via the Priya Life Science UK tracker
Sponsor
Merz Pharmaceuticals GmbH
Phase
Phase 3
Started
2019-09-16
Last updated
2026-08-21

Condition(s) studied

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

Investigational drug(s) / intervention(s)

NT 201Placebo

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
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.

Official registry record

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