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M Invernizzi, S Carda, C Molinari, D Stagno, C Cisari, A Baricich
BACKGROUND: The most important adverse effect of BoNT-A is the systemic diffusion of the toxin. There is some evidence that the administration of high doses can increase the risk of systemic diffusion and the development of clinically evident adverse effects, however an international consensus does not exist about its maximum dose. AIM: The aim of this study was to evaluate changes in autonomic heart drive induced by high doses (higher than 600 units) of incobotulinumtoxinA injection in spastic stroke patients...
August 2015: European Journal of Physical and Rehabilitation Medicine
Domenico Intiso, Valentina Simone, Filomena Di Rienzo, Andrea Iarossi, Luigi Pazienza, Andrea Santamato, Giuseppe Maruzzi, Mario Basciani
BACKGROUND: Spasticity can be a severe disabling disorder requiring high-dose injections of botulinum toxin type A (BoNT-A). Efficacy and safety of high BoNT-A doses in reducing multi-level spasticity of subjects with brain injury and cerebral palsy were investigated. Pain and functional outcome were also assessed. METHOD: High doses (up to 840 IU) of incobotulinumtoxinA were injected in adult subjects with severe spasticity of the upper and lower limbs due to brain injury (BI) and cerebral palsy (CP)...
2014: NeuroRehabilitation
Elena I Gubanova, Olga S Panova, Elena A Sanchez, Maria Y Rodina, Polina A Starovatova
INTRODUCTION: IncobotulinumtoxinA (Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™; botulinum toxin type A, free from complexing proteins [150 kDa], NT 201; Merz Pharmaceuticals GmbH, Frankfurt, Germany) is an effective and well-tolerated treatment for a variety of facial wrinkles. OBJECTIVE: To determine the efficacy and safety of incobotulinumtoxinA for the treatment of platysmal bands. METHODS: Women, 35-65 years of age, with platysmal bands scoring 2 or 3 on the validated 5-point Merz dynamic platysmal bands scale received a total of 60 U incobotulinumtoxinA divided between four platysmal bands (20 U in both medial bands and 10 U in both lateral bands)...
December 2013: Journal of Drugs in Dermatology: JDD
Martina Kerscher, Yana Yutskovskaya, Timothy Corcoran Flynn
IncobotulinumtoxinA (Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™) is a botulinum toxin type A that differs from other commercially available botulinum toxin type A preparations in that it is free from complexing proteins ([150 kDa]/NT 201). The proven efficacy of incobotulinumtoxinA in various therapeutic indications preceded its use in the field of esthetic medicine, where it is widely approved for the treatment of glabellar frown lines on the basis of positive efficacy and safety findings from a number of clinical trials...
June 1, 2013: Journal of Drugs in Dermatology: JDD
Virgilio Gerald H Evidente, Hubert H Fernandez, Mark S LeDoux, Allison Brashear, Susanne Grafe, Angelika Hanschmann, Cynthia L Comella
IncobotulinumtoxinA (Xeomin(®), NT 201), a preparation without accessory (complexing) proteins, has shown comparable efficacy and safety to onabotulinumtoxinA in treating cervical dystonia (CD). This study evaluated the efficacy and safety of repeated incobotulinumtoxinA injections in subjects with CD. Following a ≤20-week placebo-controlled, randomized, double-blind, single-dose main period, subjects could enter a ≤68-week prospective, randomized, double-blind, repeated-dose, flexible-interval (minimum 6 weeks) extension period with 240 U or 120 U of incobotulinumtoxinA (≤5 injections)...
December 2013: Journal of Neural Transmission
Dirk Dressler, Sebastian Paus, Andrea Seitzinger, Bernd Gebhardt, Andreas Kupsch
INTRODUCTION: Previously, controlled trials have demonstrated the efficacy and tolerability of fixed doses of incobotulinumtoxinA (Xeomin, NT 201, botulinum toxin type A free from complexing proteins) to treat cervical dystonia (CD). To explore the clinical relevance of these findings, this study evaluated long-term use of flexible dosing regimens of incobotulinumtoxinA in a setting close to real-life clinical practice. METHODS: Patients with CD received five injection sessions of incobotulinumtoxinA using flexible intervals (10-24 weeks) and dosing (≤300 Units) based on patients' needs...
September 2013: Journal of Neurology, Neurosurgery, and Psychiatry
A Santamato, M F Micello, F Panza, F Fortunato, A Pilotto, A Giustini, A Testa, P Fiore, M Ranieri, R Spidalieri
BACKGROUND: In recent years, NT 201, a new botulinum toxin type A (BTX-A) free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity. AIM: To assess the safety and evaluate the effects of BTX-A NT 201 free from complexing proteins for the treatment of post-stroke lower limb spasticity evaluating spasticity grade, passive ankle dorsi-flexion motion, and muscle's spasms, as well as its efficacy and rate of satisfaction for patients and for the physicians...
August 2013: European Journal of Physical and Rehabilitation Medicine
Daniel D Truong, Stephen M Gollomp, Joseph Jankovic, Peter A LeWitt, Michael Marx, Angelika Hanschmann, Hubert H Fernandez
IncobotulinumtoxinA (Xeomin(®), NT 201) is a purified botulinum toxin type A free from accessory (complexing) proteins. Previous studies evaluated single sets of incobotulinumtoxinA injections for the treatment of blepharospasm. Individualized injection intervals and other potential determinants of efficacy and safety need to be evaluated in a prospective, longitudinal study. Subjects with blepharospasm who completed a ≤ 20 weeks double-blind, placebo-controlled main period entered a ≤ 69 weeks open-label extension period (OLEX) and received ≤ 5 additional incobotulinumtoxinA treatments at flexible doses (≤ 50 U per eye) and flexible injection intervals (minimum of 6 weeks)...
September 2013: Journal of Neural Transmission
Alastair Carruthers, Jean Carruthers, William P Coleman, Lisa Donofrio, Timothy Flynn, Michael Gold, Moritz Heinz, Laura Harrington, Derek Jones, David McDaniel, Thomas Rohrer, Andrea Schlöbe, Nowell Solish, Robert A Weiss
BACKGROUND: Botulinum toxin type A is a proven, effective aesthetic treatment for glabellar frown lines. IncobotulinumtoxinA (NT 201, Xeomin/Xeomeen/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a 150-kDa botulinum toxin type A free of complexing proteins. OBJECTIVE: To assess the efficacy and safety of incobotulinumtoxinA in a randomized, double-blind, placebo-controlled, Phase III study in patients with moderate to severe glabellar frown lines. MATERIALS AND METHODS: Two hundred seventy-six patients were randomized 2:1 to receive a single injection of 20 U of incobotulinumtoxinA or placebo, respectively...
April 2013: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
Andrea Santamato, Francesco Panza, Maurizio Ranieri, Vincenza Frisardi, Maria Francesca Micello, Serena Filoni, Francesca Fortunato, Domenico Intiso, Mario Basciani, Giancarlo Logroscino, Pietro Fiore
Botulinum toxin type A (BTX-A) represents the gold standard therapy for focal spasticity after stroke, with low prevalence of complications, reversibility, and efficacy in reducing spastic hypertonia. Current guidelines suggest the employment of a dosage up to 600 units (U) of BTX-A to treat spasticity after stroke, to avoid important adverse effects and the development of antibodies against the neurotoxin. In recent years, NT 201, a new BTX-A free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity...
March 2013: Journal of Neural Transmission
P Fiore, A Santamato, M Ranieri, R G Bellomo, R Saggini, F Panza, G Megna, G Cristella, M Megna
A new preparation of botulinum toxin type A called NT 201, free from complexing proteins, potentially with low antigenicity has been used in the therapy of spasticity in stroke patients. This was an open-label study reported the safety and the efficacy of one-year treatment with NT 201 evaluating the therapeutic effect on functional disability and on quality of life in upper limb spasticity after stroke. Patients received a botulinum toxin therapy in the upper injected intramuscularly. After inoculation, patients were submitted to a motor rehabilitation program for upper limb injected three times/week...
January 2012: International Journal of Immunopathology and Pharmacology
Reiner Benecke
Botulinum toxin type A is a 150 kD protein produced by Clostridium botulinum, which exists in a complex with up to six additional proteins. The ability of botulinum toxin to inhibit acetylcholine release at the neuromuscular junction has been exploited for use in medical conditions characterized by muscle hyperactivity. As such, botulinum toxin is widely recommended by international treatment guidelines for movement disorders and it has a plethora of other clinical and cosmetic indications. The chronic nature of these conditions requires repeated injections of botulinum toxin, usually every few months...
April 1, 2012: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Timothy Corcoran Flynn
AIM:   To present the latest findings and future developments in the cosmetic use of botulinum neurotoxin. METHODS:   Review of recent literature and new scientific developments. RESULTS:   Botulinum neurotoxin type A preparations onabotulinumtoxinA (BOTOX(®) Cosmetic/Vistabel(®), Allergan Inc.) and abobotulinumtoxinA (Dysport(®) /Azzalure(®) /Reloxin(®) , Ipsen Pharma,) have been used for many years and are effective and well tolerated for facial esthetic procedures...
March 2012: Journal of Cosmetic Dermatology
Matthias Imhof, Ulrich Kühne
OBJECTIVE: To investigate the efficacy and safety of incobotulinumtoxinA (also known as botulinum toxin type A [150 kDa], free from complexing proteins, or previously as NT 201), for the treatment of glabellar frown lines, in a prospective, open-label, multicenter, Phase III trial. DESIGN: The study was a prospective, open-label, multicenter, international, Phase III clinical study. Subjects with moderate-to-severe glabellar frown lines at maximum frown, as assessed by the investigator according to the facial wrinkle scale, were given one intramuscular treatment of 20U incobotulinumtoxinA, administered as 0...
October 2011: Journal of Clinical and Aesthetic Dermatology
Cynthia L Comella, Joseph Jankovic, Daniel D Truong, Angelika Hanschmann, Susanne Grafe
OBJECTIVE: IncobotulinumtoxinA differs from available formulations in that it does not have accessory proteins. IncobotulinumtoxinA has previously shown non-inferiority to onabotulinumtoxinA for the treatment of CD with a 1:1 dosing regimen. The objective of this study was to compare the safety and efficacy of incobotulinumtoxinA (120 U, 240 U; Merz Pharmaceuticals) to placebo in subjects with cervical dystonia (CD). METHODS: This was a prospective, double-blind, randomized, placebo-controlled, multicenter clinical trial in botulinum toxin-treated or toxin-naïve CD patients...
September 15, 2011: Journal of the Neurological Sciences
Petr Kaňovský, Jaroslaw Slawek, Zoltan Denes, Thomas Platz, Georg Comes, Susanne Grafe, Irena Pulte
OBJECTIVE: To investigate the efficacy and safety of repeated treatment with incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in post-stroke upper limb spasticity. PATIENTS AND DESIGN: After completing a double-blind, placebo- controlled, multicentre study (up to 20 weeks), 145 patients received up to 5 additional sets of NT 201 injections for an open-label extension period of up to 69 weeks. METHODS: Upper limb muscle groups were treated as clinically indicated; injection intervals were ≥ 12 weeks...
May 2011: Journal of Rehabilitation Medicine
Joseph Jankovic, Cynthia Comella, Angelika Hanschmann, Susanne Grafe
IncobotulinumtoxinA (NT 201, Xeomin) is a highly purified botulinum neurotoxin type A formulation, free from complexing proteins. A randomized, placebo-controlled, double-blind trial of efficacy and safety compared incobotulinumtoxinA (up to 50 U per eye) to placebo administered in a single treatment session to patients with blepharospasm. All patients had documented satisfactory response to 2 previous treatments with botulinum neurotoxin type A other than incobotulinumtoxinA and had Jankovic Rating Scale severity subscores ≥ 2...
July 2011: Movement Disorders: Official Journal of the Movement Disorder Society
Gerhard Sattler, Michael J Callander, Doris Grablowitz, Torsten Walker, Eva K Bee, Berthold Rzany, Timothy Corcoran Flynn, Alastair Carruthers
BACKGROUND: Use of botulinum toxin for esthetic purposes has rapidly expanded over the last 20 years. IncobotulinumtoxinA, also known as NT 201, is a new botulinum toxin type A (150 kDa) that is free from complexing proteins. OBJECTIVES: A prospective, multicenter, randomized, rater- and patient-blind, international Phase III trial to investigate the noninferiority of incobotulinumtoxinA to another botulinum toxin type A, onabotulinumtoxinA, in the treatment of glabellar frown lines...
December 2010: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
Gerhard Sattler
Botulinum neurotoxin type A (BTX-A) preparations are well established for cosmetic use. BTX-A inhibits the release of acetylcholine, resulting in temporary muscle paralysis, which has been utilized successfully to treat glabellar frown lines, periorbital wrinkles and other facial enhancement procedures. Two BTX-A products are approved for aesthetic procedures in the United States (U.S.) and Europe, and a next generation of preparations free from complexing proteins has recently been approved in Germany. Despite established efficacy profiles, concerns remain regarding the propensity for immunogenic reactions, which can lead to premature loss of effect and secondary therapy failure...
September 2010: Journal of Drugs in Dermatology: JDD
Wen-Yi Chen, Jwo-Leun Lee, Yia-Wun Liang, Chin-Tun Hung, Yu-Hui Lin
This paper provides a new assessment of the most recent premium policy - the second-generation National Health Insurance (NHI) policy under Taiwan's NHI system. The willingness to pay (WTP) value for a universal coverage NHI plan is NT$201 per month and NT$940 per month for an individual level and for a household level, respectively. We find that the WTP rate is approximately 3.89% of monthly household income, consistent with the range of the new premium rate (2.5-4% of monthly household income) proposed by Taiwan's government...
October 2008: Expert Review of Pharmacoeconomics & Outcomes Research
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