Lizhen Pan, Hans Bigalke, Bruno Kopp, Lingjing Jin, Dirk Dressler
LanbotulinumtoxinA (LAN) is manufactured and registered in China since 1994. Despite its widespread use in China and its increasing use in other Asian countries and in South America, it is not yet well known elsewhere. We wanted to compare its potency labelling using the mouse diaphragm assay (MDA), an isolated muscle model for botulinum toxin (BT) potency measurements, which is superior to clinical tests and which was recently refined as an alternative batch release assay for BT manufacturing. We also wanted to estimate LAN manufacturing quality by testing its inter-batch potency consistency...
December 2019: Journal of Neural Transmission
Audrey Chun, Isaiah Levy, Ajax Yang, Andrew Delgado, Chung-Ying Tsai, Eric Leung, Kristell Taylor, Stephanie Kolakowsky-Hayner, Vincent Huang, Miguel Escalon, Thomas N Bryce
Study design: Randomized, double-blinded, placebo-controlled, cross-over study. Objective: To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain. Setting: Outpatient SCI clinic, New York, USA. Methods: Participants were randomized to receive subcutaneous injections of either placebo or BoNTA with follow-up (office visit, telephone, or e-mail) at 2, 4, 8, and 12 weeks to assess the magnitude of pain relief post injection...
2019: Spinal Cord Series and Cases
Angela Jochim, Tobias Meindl, Christoph Huber, Tobias Mantel, Silke Zwirner, Florian Castrop, Bernhard Haslinger
INTRODUCTION: Thirty years after their approval, botulinum toxin injections still are the first-line therapy for blepharospasm. The aim of our study was to analyze long-term data concerning safety and efficacy in a large cohort over decades. METHODS: Treatment data of all patients with blepharospasm and Meige´s syndrome in our outpatient clinic having undergone at least three subsequent treatment sessions with current onabotulinumtoxinA or abobotulinumtoxin A were analyzed with respect to the course of dose, effect duration, side effects, patients´ satisfaction and occurrence/reasons for treatment discontinuation...
October 19, 2019: Journal of Neurology
Rohit Kakar
No abstract text is available yet for this article.
October 14, 2019: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
Melanie D Palm, Julius Few, Tapan Patel, Marva Safa, Adrienne Drinkwater, Cheri Mao, Julie K Garcia
BACKGROUND: Millennials (aged 18-34 years) represent a growing segment of the facial aesthetic market. OBJECTIVE: To evaluate investigator-assessed efficacy, patient-reported outcomes (PROs), and safety for millennials versus subjects aged at least 35 years after onabotulinumtoxinA treatment of forehead lines (FHL) across 2 phase 3 studies. METHODS: Eligible subjects with moderate to severe FHL received onabotulinumtoxinA (FHL: 20 U; glabellar lines: 20 U, with/without 24 U in crow's feet line regions) or placebo...
October 14, 2019: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
Mitchell F Brin, Suresh Durgam, Arlene Lum, Lynn James, Jeen Liu, Michael E Thase, Armin Szegedi
This 24-week double-blind placebo-controlled multicenter randomized phase 2 trial evaluated efficacy and safety of onabotulinumtoxinA (onabotA; BOTOX) vs. placebo for major depressive disorder (MDD) [NCT02116361]. Primary endpoint was the change in Montgomery-Åsberg Depression Rating Scale (MADRS); secondary endpoints were Clinical Global Impressions-Severity and 17-item Hamilton Depression Rating Scale at week 6. A total of 255 adult females were treated. OnabotA 30 U approached significance compared to placebo on MADRS (mixed-effect model repeated measures least-squares mean difference: -3...
October 11, 2019: International Clinical Psychopharmacology
Gali Levy, Lior Lowenstein
INTRODUCTION: Overactive bladder (OAB), the most common subtype of urinary incontinence, has a heavy price on quality of life, especially on sexual life. Unfortunately, most women rarely voice the worsening of sexual function, especially those who already suffer from OAB symptoms. It has been demonstrated that patients who suffer from OAB score lower on Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire and Female Sexual Function Index scores, meaning that their sexual function is debilitated...
October 9, 2019: Sexual Medicine
Samir Derisavifard, Laura Giusto, Patricia Zahner, Jessica Rueb, Howard B Goldman
OBJECTIVES: To evaluate differences in adverse events (AE) in asymptomatic patients with a positive urine dip (UD) at time of intradetrusor onabotulinumtoxinA (BTX-A) injection versus those with a defined negative UD. MATERIALS & METHODS: All intradetrusor BTX-A injections were retrospectively reviewed at a single institution between 2016 and 2018. Exclusion criteria included an indwelling catheter, recent positive urine culture, recent antibiotic course, or absence of UD on the day of injection...
October 7, 2019: Urology
Jessica Ailani, Eric Pearlman, Qi Zhang, Abraham J Nagy, Kory Schuh, Sheena K Aurora
BACKGROUND AND PURPOSE: Humanized monoclonal antibody galcanezumab, which binds to calcitonin gene-related peptide, has shown efficacy for episodic and chronic migraine prevention. These analyses evaluated galcanezumab response for migraine headache prevention in patients who previously failed onabotulinumtoxinA ("nonresponse" or "inadequate response" or safety reasons). METHODS: Post hoc analyses included data from 3 double-blind, placebo-controlled, Phase 3 episodic or chronic migraine studies; 2,886 patients randomly received 120mg or 240mg galcanezumab or placebo...
October 8, 2019: European Journal of Neurology: the Official Journal of the European Federation of Neurological Societies
Shachar Aharony, Mikolaj Przydacz, Ornella L Van Ba, Jacques Corcos
AIM: To assess the impact of asymptomatic bacteriuria (ASB) on the safety and efficacy of intradetrusor onabotulinumtoxinA injections in patients with overactive bladder and neurogenic detrusor overactivity. METHODS: We reviewed the medical records of patients who had received onabotulinumtoxinA between 2009 and 2014. Safety analysis was based on the appearance of urinary tract infections (UTIs), hematuria, and need for hospitalization because of related adverse event(s) in the month after injection...
October 2, 2019: Neurourology and Urodynamics
Georgia Hollier-Hann, Alistair Curry, Kateryna Onishchenko, Ron Akehurst, Fayyaz Ahmed, Brendan Davies, Ian Keyzor
Aims: OnabotulinumtoxinA is recommended by NICE for the treatment of chronic migraine. This economic evaluation provides updated estimates of the cost-effectiveness of onabotulinumtoxinA for chronic migraine using new utility estimates in an existing model structure. Methods: A previously published model was revised to include EQ-5D utility estimates from a large observational study (REPOSE; n = 633). Efficacy data were taken from the pooled phase III PREEMPT clinical trial program, while resource utilization estimates were obtained from the International Burden of Migraine Study (IBMS)...
October 3, 2019: Journal of Medical Economics
Patricia Ogilvie, Alexander Z Rivkin, Steven Dayan, Steven G Yoelin, Kristin E Larsen, Sepideh Varon, Julie K Garcia
BACKGROUND: Understanding the subjects' perspective is critical for successfully treating upper facial lines. OBJECTIVE: To understand subjects' self-perception and overall satisfaction after onabotulinumtoxinA treatment for forehead and glabellar lines. METHODS: This analysis pooled data from two 12-month, pivotal phase 3 studies in which toxin-naive subjects received onabotulinumtoxinA 40 U or placebo for treatment of upper facial lines...
September 23, 2019: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
John F Rothrock, Aubrey Manack Adams, Richard B Lipton, Stephen D Silberstein, Esther Jo, Xiang Zhao, Andrew M Blumenfeld
OBJECTIVE: To compare effectiveness of onabotulinumtoxinA and topiramate for chronic migraine (CM) prevention. BACKGROUND: The efficacy* of onabotulinumtoxinA and topiramate has been established in placebo-controlled randomized clinical trials (*defined as the benefit of treatment under ideal conditions). The effectiveness* of the 2 preventive treatments, however, has not been established (*the benefit of treatment under real-world conditions, representing a blend of efficacy and tolerability)...
September 26, 2019: Headache
Maryam Oskoui, Tamara Pringsheim, Lori Billinghurst, Sonja Potrebic, Elaine M Gersz, David Gloss, Yolanda Holler-Managan, Emily Leininger, Nicole Licking, Kenneth Mack, Scott W Powers, Michael Sowell, M Cristina Victorio, Marcy Yonker, Heather Zanitsch, Andrew D Hershey
OBJECTIVE: To provide updated evidence-based recommendations for migraine prevention using pharmacologic treatment with or without cognitive behavioral therapy in the pediatric population. METHODS: The authors systematically reviewed literature from January 2003 to August 2017 and developed practice recommendations using the American Academy of Neurology 2011 process, as amended. RESULTS: Fifteen class I-III studies on migraine prevention in children in adolescents met inclusion criteria...
September 2019: Headache
Jocelyn S Hu, Elyse Fiore Pierre
Urinary incontinence is a common problem among women worldwide, resulting in a substantial economic burden and decreased quality of life. The Women's Preventive Services Initiative is the only major organization that recommends annual screening for urinary incontinence in all women despite low to insufficient evidence regarding effectiveness and accuracy of methods. No other major organization endorses screening. Initial evaluation should include determining whether incontinence is transient or chronic; the subtype of incontinence; and identifying any red flag findings that warrant subspecialist referral such as significant pelvic organ prolapse or suspected fistula...
September 15, 2019: American Family Physician
Andrew Schuler, Jesse Veenstra, David Ozog
Botulinum toxin type A (BTA) is a neurotoxic protein that prevents the release of neurotransmitters from presynaptic nerves and has shown promise in treating neuropathic pain. Recently, BTA has been used to treat painful keloids and scars. We present a patient with refractory neuropathic pain in a normotrophic spread-scar treated with the injection of BTA. A 47-year-old Caucasian female with a history of invasive melanoma of the left upper arm presented with pain in her excision scar, which she described as a “pins and needles” sensation alternating with a dull, deep ache...
September 1, 2019: Journal of Drugs in Dermatology: JDD
Alina Masters-Israilov, Matthew S Robbins
OBJECTIVE: To evaluate the frequency and features of onabotulinumtoxinA (onabotA) wear-off in chronic migraine (CM). BACKGROUND: Clinical experience suggests that patients with CM frequently perceive onabotA treatment duration <12 weeks, but this phenomenon has not been well explored. METHODS: This study was a retrospective chart review of patients (n = 143) with CM initiated on onabotA over a 2-year period. Wear-off was considered present with the phrase documented, a quantitative headache day increase, or increased use of abortive medications, bridging therapies or emergency department visits in the 6 weeks preceding the subsequent administration...
September 16, 2019: Headache
Makoto Kawashima, Kiyonori Harii, Yuki Horiuchi, Emily Seidman, Xiaofang Lei, René Hopfinger, Elisabeth Lee
BACKGROUND: OnabotulinumtoxinA treatment for glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects. OBJECTIVE: To assess safety and efficacy of repeated onabotulinumtoxinA for moderate to severe GL and CFL in Japanese subjects. METHODS: This 13-month, double-blind, Phase 3 study randomized subjects to onabotulinumtoxinA 44 U (n = 48) or 32 U (n = 53) for CFL and GL for up to 5 treatments (CFL: 24 U or 12 U; GL: 20 U)...
September 10, 2019: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
Khashayar Dashtipour, Zoltan Mari, Joseph Jankovic, Charles H Adler, Marc Schwartz, Mitchell F Brin
OBJECTIVE: To determine the minimal clinically important change (MCIC) on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores using data from Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE), which captured real-world practices and outcomes. METHODS: Changes in the baseline TWSTRS scores (point and percentage changes) were compared to changes in the Patient and Clinician Global Impression of Change (PGIC and CGIC) ratings...
July 27, 2019: Journal of the Neurological Sciences
Roberta D'Emilio, Giuseppe Rosati
BACKGROUND: Botulinum toxin type A injection is a common aesthetic treatment that can be used alone or in combination to rejuvenate the entire face and neck. OBJECTIVES: To assess the safety and efficacy of a full-face approach with botulinum toxin type A. METHODS: This was a single-center, retrospective review of data from 189 patients receiving full-face and neck treatment with onabotulinumtoxinA in the following areas: glabellar lines, crow's feet lines, forehead lines, bunny lines, sagging nasal tip, gummy smile, marionette lines, mentalis, masseter, and lateral/anterior platysma...
September 5, 2019: Journal of Cosmetic Dermatology
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