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abobotulinumtoxinA

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https://www.readbyqxmd.com/read/29781237/investigation-of-mixed-model-repeated-measures-analyses-and-non-linear-random-coefficient-models-in-the-context-of-long-term-efficacy-data
#1
Bruno Delafont, Kevin Carroll, Claire Vilain, Emmanuel Pham
The longitudinal data from 2 published clinical trials in adult subjects with upper limb spasticity (a randomized placebo-controlled study [NCT01313299] and its long-term open-label extension [NCT01313312]) were combined. Their study designs involved repeat intramuscular injections of abobotulinumtoxinA (Dysport®), and efficacy endpoints were collected accordingly. With the objective of characterizing the pattern of response across cycles, Mixed Model Repeated Measures analyses and Non-Linear Random Coefficient (NLRC) analyses were performed and their results compared...
May 20, 2018: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/29740633/effect-of-early-use-of-abobotulinumtoxina-after-stroke-on-spasticity-progression-protocol-for-a-randomised-controlled-pilot-study-in-adult-subjects-with-moderate-to-severe-upper-limb-spasticity-ontime-pilot
#2
Keng He Kong, Jovita Balcaitiene, Hugues Berard, Pascal Maisonobe, Khean Jin Goh, Witsanu Kumthornthip, Raymond L Rosales
Introduction: Approximately 15 million people suffer a stroke annually, up to 40% of which may develop spasticity, which can result in impaired limb function, pain and associated involuntary movements affecting motor control.Robust clinical data on spasticity progression, associated symptoms development and functional impairment is scarce. Additionally, maximal duration of muscle tone reduction following botulinum toxin type A (BoNT-A) injections remains undetermined. The ONTIME pilot study aims to explore these issues and evaluate whether abobotulinumtoxinA 500 U (Dysport® ; Ipsen) administered intramuscularly within 12 weeks following stroke delays the appearance or progression of symptomatic (disabling) upper limb spasticity (ULS)...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29625849/abobotulinumtoxina-efficacy-and-safety-in-children-with-equinus-foot-previously-treated-with-botulinum-toxin
#3
Edward Dabrowski, Marcin Bonikowski, Mark Gormley, Magali Volteau, Philippe Picaut, Mauricio R Delgado
BACKGROUND: The effects of botulinum toxin are transient, and repeat injections are required in children with lower-limb spasticity. However, the efficacy of botulinum toxin in patients who have received previous injections has remained largely unexplored. METHODS: We present subgroup analyses of a phase III study conducted in ambulatory children (aged two to 17) with spastic equinus foot. Patients were randomized to single doses of abobotulinumtoxinA 10 U/kg/leg, 15 U/kg/leg, or placebo injected into the gastrocnemius-soleus complex (one or both legs)...
February 7, 2018: Pediatric Neurology
https://www.readbyqxmd.com/read/29542022/pilot-single-blind-trial-of-abobotulinumtoxina-in-oromandibular-dystonia
#4
Laura M Scorr, Michael R Silver, John Hanfelt, Elaine Sperin, Alan Freeman, H A Jinnah, Stewart A Factor
Oromandibular dystonia (OMD) causes involuntary movements of masticatory and lingual muscles impairing eating, speaking, and swallowing. Treatment options are limited. The objective of this study was to determine the safety and efficacy of abobotulinumtoxinA (aboBoNTA) in OMD. A dose-finding study (phase 1) followed by a single session, prospective, single-blind trial (phase 2) was carried out. OMD subjects were evaluated at baseline, 6 and 12 weeks. Muscles injected were tailored to individual symptoms using EMG guidance, but the aboBoNTA dose for each muscle was pre-specified based on phase 1 results...
April 2018: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
https://www.readbyqxmd.com/read/29530726/minimal-clinically-important-change-in-the-toronto-western-spasmodic-torticollis-rating-scale
#5
Alberto J Espay, Richard Trosch, Gustavo Suarez, Jonathan Johnson, Dominic Marchese, Cynthia Comella
OBJECTIVES: To characterize the minimal clinically important change (MCIC) after treatment in cervical dystonia patients using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). METHODS: Changes in the TWSTRS from an observational study of abobotulinumtoxinA in the routine management of cervical dystonia (NCT01314365) were analyzed using the Patient Global Impression of Change (PGIC) as anchor. RESULTS: For the overall population (N = 304, baseline TWSTRS-Total score 43...
March 7, 2018: Parkinsonism & related Disorders
https://www.readbyqxmd.com/read/29408357/evidence-on-botulinum-toxin-in-selected-disorders
#6
Elina Zakin, David Simpson
Botulinum toxin (BoNT) is a neurotoxin produced by the bacteria Clostridium botulinum that has become widely used for various neurologic indications. The four toxin formulations currently available for use in the United States (approved by the Food and Drug Administration) are onabotulinumtoxinA (Botox® ), abobotulinumtoxinA (Dysport® ), incobotulinumtoxinA (Xeomin® ), and rimabotulinumtoxinB (Myobloc® ). While the FDA-approved labels indicate that potency conversions should not be done, literature supports relative dose equivalents of approximately 1:1:2-4:50-100, respectively...
June 1, 2018: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/29343142/a-500-u-2-ml-dilution-of-abobotulinumtoxina-vs-placebo-randomized-study-in-cervical-dystonia
#7
Mark F Lew, Allison Brashear, Khashayar Dashtipour, Stuart Isaacson, Robert A Hauser, Pascal Maisonobe, Daniel Snyder, William Ondo
Purpose/aim: AbobotulinumtoxinA (Dysport®, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ, USA) is an acetylcholine release inhibitor and a neuromuscular blocking agent. The United States prescribing information for abobotulinumtoxinA previously indicated only one dilution for cervical dystonia: 500 U/1 mL. Clinical trial data supporting a larger volume with a 500 U/2 mL dilution would offer clinicians flexibility with injection volume to better meet patient needs. MATERIALS AND METHODS: We conducted a 12-week, phase 3b, multicenter, randomized, double-blind, placebo-controlled trial (NCT01753310)...
January 17, 2018: International Journal of Neuroscience
https://www.readbyqxmd.com/read/29280866/the-impact-of-botulinum-toxin-on-brow-height-and-morphology-a-randomized-controlled-trial
#8
RANDOMIZED CONTROLLED TRIAL
Joseph S El-Khoury, Samer F Jabbour, Cyril J Awaida, Youssef A Rayess, Elio G Kechichian, Marwan W Nasr
BACKGROUND: Previous reports have objectively demonstrated the efficacy of botulinum toxin for brow elevation. No clinical trial has compared the variation of the eyebrow shape and height when the lateral eyebrow depressors are injected alone or in combination with the medial eyebrow depressors. METHODS: A prospective, randomized, controlled study was designed to evaluate and compare the effect of two different botulinum toxin injection techniques on brow shape and position...
January 2018: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/29230798/botulinum-toxin-type-a-therapy-for-cervical-dystonia
#9
REVIEW
Mafalda Castelão, Raquel E Marques, Gonçalo S Duarte, Filipe B Rodrigues, Joaquim Ferreira, Cristina Sampaio, Austen P Moore, João Costa
BACKGROUND: This is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia and is a highly disabling movement disorder characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition. OBJECTIVES: To compare the efficacy, safety, and tolerability of botulinum toxin type A (BtA) versus placebo in people with cervical dystonia...
December 12, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29106437/does-increasing-the-dose-of-abobotulinumtoxina-impact-the-duration-of-effectiveness-for-the-treatment-of-moderate-to-severe-glabellar-lines
#10
MULTICENTER STUDY
John H Joseph, Laura L Eaton, James Robinson, Allison Pontius, Edwin F Williams
OBJECTIVE: To evaluate the duration of effect of a single dose of 120 units of abobotulinumtoxinA for the treatment of moderate to severe glabellar lines. DESIGN: Investigator-initiated, prospective, multi-center, open-label study. MATERIAL AND METHODS: This open-label trial of thirty subjects with moderate to severe glabellar lines at maximum frown was per- formed at 2 private plastic surgery clinics. 120 units of abobotulinumtoxinA was injected in 5 equal aliquots (24 units each) into each of 5 injection sites in the glabellar complex...
December 1, 2016: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29093068/efficacy-and-safety-of-abobotulinumtoxina-in-spastic-lower-limb-randomized-trial-and-extension
#11
RANDOMIZED CONTROLLED TRIAL
Jean-Michel Gracies, Alberto Esquenazi, Allison Brashear, Marta Banach, Serdar Kocer, Robert Jech, Svetlana Khatkova, Ján Benetin, Michele Vecchio, Peter McAllister, Jan Ilkowski, Stanislaw Ochudlo, France Catus, Anne Sophie Grandoulier, Claire Vilain, Philippe Picaut
OBJECTIVE: To demonstrate single abobotulinumtoxinA injection efficacy in lower limb vs placebo for adults with chronic hemiparesis and assess long-term safety and efficacy of repeated injections. METHODS: In a multicenter, double-blind, randomized, placebo-controlled, single-cycle study followed by a 1-year open-label, multiple-cycle extension, adults ≥6 months after stroke/brain injury received one lower limb injection (abobotulinumtoxinA 1,000 U, abobotulinumtoxinA 1,500 U, placebo) followed by ≤4 open-label cycles (1,000, 1,500 U) at ≥12-week intervals...
November 28, 2017: Neurology
https://www.readbyqxmd.com/read/29064991/efficacy-of-incobotulinumtoxina-for-the-treatment-of-glabellar-frown-lines-in-male-subjects-post-hoc-analyses-from-randomized-double-blind-pivotal-studies
#12
RANDOMIZED CONTROLLED TRIAL
Derek H Jones, Martina Kerscher, Thorin Geister, Michael A Hast, Petra Weissenberger
BACKGROUND: Males are increasingly seeking minimally invasive cosmetic procedures such as botulinum toxin injection. However, few studies have specifically examined the efficacy of such procedures among men. OBJECTIVE: To assess the efficacy of incobotulinumtoxinA for treating glabellar frown lines (GFLs) in men. METHODS: Three incobotulinumtoxinA studies were included in post hoc analyses of responder rates: 2 pivotal Phase 3 US registration studies for GFLs (n = 55 males in a pooled analysis) and a European pivotal Phase 3 study for upper facial lines (UFLs; n = 21 males)...
November 2017: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
https://www.readbyqxmd.com/read/28973094/effect-of-3-commercially-available-botulinum-toxin-neuromodulators-on-facial-synkinesis-a-randomized-clinical-trial
#13
Andrew J Thomas, Michael O Larson, Samuel Braden, Richard B Cannon, P Daniel Ward
Importance: Botulinum toxin neuromodulators are an important treatment for facial synkinesis. Whether a difference in efficacy exists among the 3 different botulinum neuromodulators used in treating this condition remains unknown. Objective: To evaluate the effectiveness of 3 commercially available botulinum toxin neuromodulators in the treatment of facial synkinesis. Design, Setting, and Participants: In this single-blind, 3-arm comparison randomized clinical trial, 28 patients at the Facial Nerve Center, University of Utah, Salt Lake City, were randomized to onabotulinumtoxinA, abobotulinumtoxinA, or incobotulinumtoxinA treatment...
March 1, 2018: JAMA Facial Plastic Surgery
https://www.readbyqxmd.com/read/28914131/safety-and-efficacy-of-repeat-open-label-abobotulinumtoxina-treatment-in-pediatric-cerebral-palsy
#14
Mauricio R Delgado, Marcin Bonikowski, Jorge Carranza, Edward Dabrowski, Dennis Matthews, Barry Russman, Ann Tilton, Juan Carlos Velez, Anne-Sophie Grandoulier, Philippe Picaut
This was a prospective, repeat-treatment, open-label study (NCT01251380) of abobotulinumtoxinA for the management of lower limb spasticity in children who had completed a double-blind study. Children (2-17 years) received injections into the gastrocnemius-soleus complex, and other distal and proximal muscles as required (maximum total dose per injection cycle: 30 U/kg or 1000U). A total of 216 of the 241 double-blind patients entered the extension study and 207 received ≥1 open label injection into the gastrocnemius-soleus; 17-24% of patients also had injections into the hamstrings...
November 2017: Journal of Child Neurology
https://www.readbyqxmd.com/read/28657917/patient-registry-of-spasticity-care-world-data-analysis-based-on-physician-experience
#15
MULTICENTER STUDY
Alberto Esquenazi, Stella Lee, Nathaniel Mayer, Roser Garreta, Atul Patel, Elie Elovic, Stephen Koelbel, Gerard Francisco, Iris Reuter
OBJECTIVE: The aim of the study was to report physician experience-based "real-world" treatment patterns with botulinum toxin type A in patients with stroke and traumatic brain injury. DESIGN: A prospective, multicenter, international observational registry design was used. RESULTS: Six hundred twenty-seven participants with stroke and 132 participants with traumatic brain injury were assessed and treated by 17 more experienced physicians and 12 less experienced physicians...
December 2017: American Journal of Physical Medicine & Rehabilitation
https://www.readbyqxmd.com/read/28654586/botulinum-toxin-for-neck-rejuvenation-assessing-efficacy-and-redefining-patient-selection
#16
Samer F Jabbour, Elio G Kechichian, Cyril J Awaida, Roland R Tomb, Marwan W Nasr
BACKGROUND: The "Nefertiti lift" consists of injecting the platysmal bands and the inferior border of the mandible with botulinum toxin. No clinical trial has evaluated its effect on the different lower face and neck aging components, and little is known about the clinical characteristics that predict treatment success. METHODS: Patients were injected with abobotulinumtoxinA along the inferior border of the mandible and into the platysmal bands. Using standardized preinjection and postinjection photographs, the jowls, marionette lines, oral commissures, neck volume, and platysmal bands at maximal contraction and at rest were assessed with validated photonumeric scales...
July 2017: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/28639368/botulinum-toxin-state-of-the-art
#17
REVIEW
Joseph Jankovic
Botulinun neurotoxin (BoNT) has emerged as one of the most multipurpose therapeutic agents in modern medicine with more clinical applications than any other drug currently on the market. Initially developed in the treatment of strabismus and neurologic movement disorders, the use of botulinun neurotoxin has been expanding during the past 3 decades to include the treatment of a variety of ophthalmologic, gastrointestinal, urologic, orthopedic, dermatologic, dental, secretory, painful, cosmetic, and other conditions...
August 2017: Movement Disorders: Official Journal of the Movement Disorder Society
https://www.readbyqxmd.com/read/28634000/dose-dependent-effects-of-abobotulinumtoxina-dysport-on-spasticity-and-active-movements-in-adults-with-upper-limb-spasticity-secondary-analysis-of-a-phase-3-study
#18
Michael W O'Dell, Allison Brashear, Robert Jech, Thierry Lejeune, Philippe Marque, Djamel Bensmail, Ziyad Ayyoub, David M Simpson, Magali Volteau, Claire Vilain, Philippe Picaut, Jean Michel Gracies
BACKGROUND: AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited. OBJECTIVE: To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS. DESIGN: Secondary analysis of a phase 3 study (NCT01313299). SETTING: Multicenter, international, double-blind, placebo-controlled clinical trial...
January 2018: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28625615/efficacy-and-safety-of-abobotulinumtoxina-dysport-for-the-treatment-of-hemiparesis-in-adults-with-upper-limb-spasticity-previously-treated-with-botulinum-toxin-subanalysis-from-a-phase-3-randomized-controlled-trial
#19
Christina Marciniak, Peter McAllister, Heather Walker, Allison Brashear, Steven Edgley, Thierry Deltombe, Svetlana Khatkova, Marta Banach, Fatma Gul, Claire Vilain, Philippe Picaut, Anne-Sophie Grandoulier, Jean-Michel Gracies
OBJECTIVE: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A). DESIGN: A post hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study (NCT01313299). SETTING: A total of 34 neurology or rehabilitation clinics in 9 countries. PARTICIPANTS: Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury...
December 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28623614/abobotulinumtoxina-a-review-in-pediatric-lower-limb-spasticity
#20
REVIEW
Yahiya Y Syed
AbobotulinumtoxinA (Dysport® ) is currently the only botulinum toxin A formulation approved by the US FDA for the treatment of lower limb spasticity in pediatric patients aged ≥2 years. Intramuscular abobotulinumtoxinA was approved based on the results of a pivotal phase 3 trial in children with lower limb spasticity due to cerebral palsy. In this trial, a single treatment cycle with abobotulinumtoxinA 10-15 U/kg/leg injected into the gastrocnemius and soleus muscles significantly improved ankle plantar flexor muscle tone (primary endpoint), with abobotulinumtoxinA recipients showing a significant response to treatment relative to placebo...
August 2017: Paediatric Drugs
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