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 (PATTERN)
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Eligibility Criteria
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
Sites / Locations
- New England institute for clinical research; Merz Investigational Site #0010441Recruiting
- Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283Recruiting
- Rehabilitation Hospital, Kessler Institute for Rehabilitation, Merz Investigational Site #0010199Recruiting
- Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191
- Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440Recruiting
- University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211Recruiting
- UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082Recruiting
- University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183Recruiting
- Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237Recruiting
- St George Hospital, Department of Rehabilitation Medicine, Merz Investigational Site #0610004
- Royal Melbourne Hospital, Department of Rehabilitation Medicine; Merz Investigational Site #0610002
- CHU Brugmann Neurology; Merz investigational site #0320015Recruiting
- UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013Recruiting
- UZ Leuven Pellenberg campus; Merz investigational site #0320014Recruiting
- UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008Recruiting
- Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049Recruiting
- University Hospital Ostrava; Neurology Departement, Merz investigational site #4200024Recruiting
- Pardubice Regional Hospital; Merz investigational site #4200025Recruiting
- Fakultni nemocnice Kralovske Vinohrady, Neurology Department, Merz Investigational Site #4200050Recruiting
- Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation, Merz Investigational site #00330018Recruiting
- Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063Recruiting
- Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Médecine physique et de réadaptation, Merz investigational site #0330025Recruiting
- Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191Recruiting
- Neurologie Bewegt; Merz Investigational site #0490378
- Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071Recruiting
- Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079Recruiting
- CBBM, Institut für Neurogenetik, Haus 66; Merz Investigational Site #0490332
- DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081Recruiting
- Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302Recruiting
- St.Damjan Hospital, Kisvarda; Merz investigational site #0360019Recruiting
- University of Szeged, Department of Neurology, Merz investigational site #0360008Recruiting
- Ospedale Valduce, Villa Beretta Rehabilitation Center, Merz investigational site #0390005Recruiting
- Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018Recruiting
- IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020Recruiting
- Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017Recruiting
- Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022Recruiting
- AOUI -Ospedale Borgo Roma, U.O.C Neuroriabilitazione, Merz Investigational Site #0390014Recruiting
- Haukeland University Hospital, Dept of Neurology; Merz investigational site #0470001
- Sunnaas Rehabilitation Hospital, Merz Investigational Site #0470002
- Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077Recruiting
- Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059Recruiting
- NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101Recruiting
- Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096Recruiting
- Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100Recruiting
- Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099Recruiting
- Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023Recruiting
- Mazowiecki Szpital Brodnowski, Merz investigational site #0480064Recruiting
- Neuryt Diagnostyka I Terapia Neurologiczna, Merz investigational site #0480106Recruiting
- 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
- 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
- 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
- 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
- University Hospital Bratislav, 2nd Dept. of Neurology, Merz Investigational Site # 4210005Recruiting
- Neurologicka klinika, Fakultna nemocnica Trnava; Merz investigational site #4210009Recruiting
- Hospital Universitario La Paz, Merz Investigational Site #0340007Recruiting
- Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003Recruiting
- University Hospital of Bern, Center of Parkinson's diseases and Movement disorders (ZfPB), Merz investigational site #0410015Recruiting
- Centre Hospitalier Universitaire Vaudois - Neurorehabilitation and Physical Medicine, Merz Investigational Site #0410013Recruiting
- HFR Fribourg - Hôpital Cantonal, Department of Rehabilitation, Merz Investigational site #0410014Recruiting
- Merz Investigational Site #3800019Recruiting
- Rivne City Hospital 2, Department of Clinical Neurology and Neurorehabilitation; Merz investigational site #3800016Recruiting
- NPE "Regional Clinical Centre of Neurosurgery and Neurology" Transcarpathian Regional Council; Merz investigational site #3800014Recruiting
- Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023Recruiting
- Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047Recruiting
- The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004Recruiting
- National Hospital for Neurology and Neurosurgery - UCLH; Merz Investigational Site #0440033
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
NT 201 (IncobotulinumtoxinA, Xeomin)
Placebo
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.
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.