- Email: [email protected]
40. Efficacy and safety profile of incobotulinumtoxinA in children with cerebral palsy: randomized double-blind clinical trial
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Abstracts / Toxicon 93 (2015) S2eS67
Keywords: Botulinum; Internalization; Localization; Neuron; Release; Sorting; Trafficking 39. CLINICAL ASPECTS OF PARKINSON'S DISEASE THAT CAN BE TREATED WITH BOTULINUM TOXIN Francisco Cardoso Movement Disorders Unit, Neurology Service, UFMG, Av Pasteur 89/1107 30150-290 Belo Horizonte MG Brazil. E-mail address: [email protected] The core clinical features of Parkinson’s disease (PD)dthe most common cause of parkinsonismdare bradykinesia in association with at least one of the following features: tremor, rigidity, and postural instability. The mainstay of the treatment of PD is the use of pharmacologic agents, rehabilitation techniques, and, in selected cases, surgery. There are some other features, however, that can be successfully treated with botulinum toxin (BoNT) injections. A significant proportion of PD patients present with sialorrhea refractory to clinical treatment. Controlled trials of intraglandular injections of both botulinum toxin types A and B show that these constitute an effective and safe treatment for drooling in PD. Dystonia is also often seen in PD patients, with blepharospasm, apraxia of the eyelid opening, oromandibular dystonia, and foot dystonia being the most common types. In most instances, the latter is a feature of the disease, whereas the others are commonly part of the spectrum of levodopainduced dyskinesias. If these forms of dystonia fail to respond to conventional antiparkinsonian treatment, clinical practice shows that they can be successfully controlled with BoNT injections. There is, however, a need for controlled trials to support the effectiveness of this use of BoNTs. Finally, urinary urgency or incontinence caused by an overactive detrusor muscle is seen in at least 30% of PD patients. Several open label studies show that intradetrusor BoNT injections provide a 6-month improvement of urinary incontinence. Keywords: Dystonia; Levodopa-induced dyskinesias; Parkinsonism; Parkinson’s disease; Sialorrhea; Urinary incontinence 40. EFFICACY AND SAFETY PROFILE OF INCOBOTULINUMTOXINA IN CHILDREN WITH CEREBRAL PALSY: RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL Elena Carraro*, Enrico Trevisi, Carla De Conti, Andrea Martinuzzi Neuropediatric Rehabilitation Unit, “E. Medea” Scientific Institute, Conegliano, Italy *Corresponding author: via Costa Alta 37, Conegliano, Treviso, Italy. E-mail address: [email protected]
Introduction and Objectives: To establish the safety profile of incobotulinumtoxinA in the management of children with cerebral palsy (CP) and muscle spasticity; to compare the efficiency of incobotulinumtoxinA with that of onabotulinumtoxinA, using the same standard dose. Methods: The trial followed a randomized, double-blind, controlled design and involved the recruitment of children aged between 3 and 18 years, of both sexes, with spastic hemiplegia or diplegia in cerebral palsy (CP) who were referred to our tertiary neurorehabilitation center in northeast Italy (Conegliano). Treatment involved injection of botulinum toxin 5 U/kg for triceps: incobotulinumtoxinA in “study group” (SG), onabotulinumtoxinA in “control group” (CG). The occurrence of adverse events at 2, 10, and 90 days was recorded by caregivers in a checklist that included both common and uncommon side effects as reported in the literature. All recruited subjects were evaluated with standardized tools before and 3 months after treatment: ankle joint range of motion (RoM), modified Ashworth Scale for muscle tone, and Manual Muscle Strength Test (Medical Research Council Scale) (plantar/ dorsiflexor muscles); Gross Motor Functional Measure (GMFM). Results: Thirty-five patients were treated (CG¼18; SG¼17); the 2 groups were well balanced regarding demographics and anthropometry characteristics. At least 1 adverse event occurred in 49% of patients within the first 2 days: 46% between 2 and 10 days, and 12% between 10 and 90 days. All reported events were minor; no serious adverse event was recorded. Fatigue was the most frequent complaint. There was no significant difference in frequency and type of events between the 2 groups. There was no difference in localized reaction rates within the first 2 and 10 days (P¼0.56). The effect of treatment on clinical variables (tone, RoM, GMFM) did not differ between the 2 groups.
Conclusions: In conclusion, we show that incobotulinumtoxinA and onabotulinumtoxinA toxins share similar profiles of safety and efficacy for the treatment of lower limb spasticity in CP children. Keywords: Botulinum toxin; Cerebral palsy; Spasticity 41. EVOLUTION OF FACIAL AESTHETIC TREATMENT OVER 5 OR MORE YEARS: AN INTERNATIONAL, RETROSPECTIVE, CROSS-SECTIONAL ANALYSIS OF CONTINUOUS ONABOTULINUMTOXINA TREATMENT Alastair Carruthers a, *, Neil Sadick b, Frederic Brandt c, Ada Regina Trinidade de Almeida d, Steve Fagin e, Greg Goodman f, Hervey Rapallo g, Kevin Smith h, Sarah Darmody i, Conor Gallagher i a Carruthers Clinical Research, Vancouver, BC, Canada; b Sadick Research Group, New York, NY, USA; c Dr. Brandt Dermatology Associates, Coral Gables, FL, USA; d Hospital Do Servidor Publico Municipal, Sao Paulo, Brazil; e Aesthetic Eyelid Plastic Surgery, Boca Raton, FL, USA; f Monash University, South Yarra, Victoria, Australia; g Cannes Private Clinic, Cannes, France; h Niagara Falls Dermatology and Skin Care Center, Niagara Falls, ON, Canada; i Allergan, Irvine, CA, USA *Corresponding author: Carruthers Clinical Research, 943 West Broadway, Suite 820, Vancouver, BC, Canada. E-mail address: [email protected]
Introduction and Objectives: Assess the evolution of facial aesthetic treatment in patients receiving long-term, continuous onabotulinumtoxinA treatment. Methods: This international retrospective chart review included patients aged 18 years at first onabotulinumtoxinA aesthetic treatment with a history of 5 years of continuous onabotulinumtoxinA treatments (annual average, 2 treatments, including 1 glabellar lines [GL] treatment/year for 5 years). Medical records were reviewed for extensive data on the progression of patients’ aesthetic treatments and clinical trends during the period of widespread adoption of injectable aesthetic treatments. Results: Of 207 patients included, 194 met criteria for per-protocol analysis. Patients received onabotulinumtoxinA for a mean of 9.1±2.9 years (range, 5.0 to 16.8 years). Data were collected from 5112 treatment sessions; 4402 included GL treatment. Mean age at first injection was 46.3±9.9 years. The longer patients were treated, the younger they perceived themselves to look. GL treatment temporally preceded crow’s feet lines (CFL), followed by forehead lines (FHL). Dosing in GL and CFL remained relatively stable from 1999 to 2012, although FHL dose decreased. Most patients (85%; 165/194) received treatment with fillers, of which 111 began, on average, 38 months after first onabotulinumtoxinA treatment. The rest had received fillers previously (n¼25) or began in the same year (n¼29). Besides a cumulative increase in onabotulinumtoxinA treatments in GL, FHL, and CFL over time, there were increases in facial aesthetic treatments with injectable fillers, energy-based devices, and prescription topical creams. Adverse events were infrequent, mostly mild in severity, and declined markedly over the first year of treatment. Conclusions: Continuous onabotulinumtoxinA treatments over several years are safe and can be used in conjunction with other aesthetic treatments. Patients receiving continuous onabotulinumtoxinA treatment perceived themselves to look younger than their actual age. Keywords: Botulinum neurotoxin type A; Crow’s feet lines; FLSQ; Forehead lines; Glabellar lines; OnabotulinumtoxinA; Patient-reported outcomes; Patient satisfaction 42. LONG-LASTING FUNCTIONAL BRAIN CHANGES IN A CASE STUDY OF CERVICAL DYSTONIA TREATED WITH BOTULINUM TOXIN AND MOTOR RELEARNING TECHNIQUES A. Castagna*, F. Baglio, M. Ramella, O. Di Pasquale, A. Marzegan, A. Crippa, G. Giacobbi, J. Jonsdottir, A. Montesano IRCCS Don Carlo Gnocchi Foundation, Milan, Italy *Corresponding author: IRCCS Don Carlo Gnocchi Foundation, Via Capecelatro 66, Milan, Italy 20100, Italy. E-mail address: [email protected]
Introduction and Objectives: CD is characterized by involuntary, abnormal movements and postures of the head and neck. Current views on its pathophysiology are faulty sensorimotor integration and impaired motor planning. Efficacy of BoNT has been demonstrated, and there are
Abstracts / Toxicon 93 (2015) S2eS67
Keywords: Botulinum; Internalization; Localization; Neuron; Release; Sorting; Trafficking 39. CLINICAL ASPECTS OF PARKINSON'S DISEASE THAT CAN BE TREATED WITH BOTULINUM TOXIN Francisco Cardoso Movement Disorders Unit, Neurology Service, UFMG, Av Pasteur 89/1107 30150-290 Belo Horizonte MG Brazil. E-mail address: [email protected] The core clinical features of Parkinson’s disease (PD)dthe most common cause of parkinsonismdare bradykinesia in association with at least one of the following features: tremor, rigidity, and postural instability. The mainstay of the treatment of PD is the use of pharmacologic agents, rehabilitation techniques, and, in selected cases, surgery. There are some other features, however, that can be successfully treated with botulinum toxin (BoNT) injections. A significant proportion of PD patients present with sialorrhea refractory to clinical treatment. Controlled trials of intraglandular injections of both botulinum toxin types A and B show that these constitute an effective and safe treatment for drooling in PD. Dystonia is also often seen in PD patients, with blepharospasm, apraxia of the eyelid opening, oromandibular dystonia, and foot dystonia being the most common types. In most instances, the latter is a feature of the disease, whereas the others are commonly part of the spectrum of levodopainduced dyskinesias. If these forms of dystonia fail to respond to conventional antiparkinsonian treatment, clinical practice shows that they can be successfully controlled with BoNT injections. There is, however, a need for controlled trials to support the effectiveness of this use of BoNTs. Finally, urinary urgency or incontinence caused by an overactive detrusor muscle is seen in at least 30% of PD patients. Several open label studies show that intradetrusor BoNT injections provide a 6-month improvement of urinary incontinence. Keywords: Dystonia; Levodopa-induced dyskinesias; Parkinsonism; Parkinson’s disease; Sialorrhea; Urinary incontinence 40. EFFICACY AND SAFETY PROFILE OF INCOBOTULINUMTOXINA IN CHILDREN WITH CEREBRAL PALSY: RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL Elena Carraro*, Enrico Trevisi, Carla De Conti, Andrea Martinuzzi Neuropediatric Rehabilitation Unit, “E. Medea” Scientific Institute, Conegliano, Italy *Corresponding author: via Costa Alta 37, Conegliano, Treviso, Italy. E-mail address: [email protected]
Introduction and Objectives: To establish the safety profile of incobotulinumtoxinA in the management of children with cerebral palsy (CP) and muscle spasticity; to compare the efficiency of incobotulinumtoxinA with that of onabotulinumtoxinA, using the same standard dose. Methods: The trial followed a randomized, double-blind, controlled design and involved the recruitment of children aged between 3 and 18 years, of both sexes, with spastic hemiplegia or diplegia in cerebral palsy (CP) who were referred to our tertiary neurorehabilitation center in northeast Italy (Conegliano). Treatment involved injection of botulinum toxin 5 U/kg for triceps: incobotulinumtoxinA in “study group” (SG), onabotulinumtoxinA in “control group” (CG). The occurrence of adverse events at 2, 10, and 90 days was recorded by caregivers in a checklist that included both common and uncommon side effects as reported in the literature. All recruited subjects were evaluated with standardized tools before and 3 months after treatment: ankle joint range of motion (RoM), modified Ashworth Scale for muscle tone, and Manual Muscle Strength Test (Medical Research Council Scale) (plantar/ dorsiflexor muscles); Gross Motor Functional Measure (GMFM). Results: Thirty-five patients were treated (CG¼18; SG¼17); the 2 groups were well balanced regarding demographics and anthropometry characteristics. At least 1 adverse event occurred in 49% of patients within the first 2 days: 46% between 2 and 10 days, and 12% between 10 and 90 days. All reported events were minor; no serious adverse event was recorded. Fatigue was the most frequent complaint. There was no significant difference in frequency and type of events between the 2 groups. There was no difference in localized reaction rates within the first 2 and 10 days (P¼0.56). The effect of treatment on clinical variables (tone, RoM, GMFM) did not differ between the 2 groups.
Conclusions: In conclusion, we show that incobotulinumtoxinA and onabotulinumtoxinA toxins share similar profiles of safety and efficacy for the treatment of lower limb spasticity in CP children. Keywords: Botulinum toxin; Cerebral palsy; Spasticity 41. EVOLUTION OF FACIAL AESTHETIC TREATMENT OVER 5 OR MORE YEARS: AN INTERNATIONAL, RETROSPECTIVE, CROSS-SECTIONAL ANALYSIS OF CONTINUOUS ONABOTULINUMTOXINA TREATMENT Alastair Carruthers a, *, Neil Sadick b, Frederic Brandt c, Ada Regina Trinidade de Almeida d, Steve Fagin e, Greg Goodman f, Hervey Rapallo g, Kevin Smith h, Sarah Darmody i, Conor Gallagher i a Carruthers Clinical Research, Vancouver, BC, Canada; b Sadick Research Group, New York, NY, USA; c Dr. Brandt Dermatology Associates, Coral Gables, FL, USA; d Hospital Do Servidor Publico Municipal, Sao Paulo, Brazil; e Aesthetic Eyelid Plastic Surgery, Boca Raton, FL, USA; f Monash University, South Yarra, Victoria, Australia; g Cannes Private Clinic, Cannes, France; h Niagara Falls Dermatology and Skin Care Center, Niagara Falls, ON, Canada; i Allergan, Irvine, CA, USA *Corresponding author: Carruthers Clinical Research, 943 West Broadway, Suite 820, Vancouver, BC, Canada. E-mail address: [email protected]
Introduction and Objectives: Assess the evolution of facial aesthetic treatment in patients receiving long-term, continuous onabotulinumtoxinA treatment. Methods: This international retrospective chart review included patients aged 18 years at first onabotulinumtoxinA aesthetic treatment with a history of 5 years of continuous onabotulinumtoxinA treatments (annual average, 2 treatments, including 1 glabellar lines [GL] treatment/year for 5 years). Medical records were reviewed for extensive data on the progression of patients’ aesthetic treatments and clinical trends during the period of widespread adoption of injectable aesthetic treatments. Results: Of 207 patients included, 194 met criteria for per-protocol analysis. Patients received onabotulinumtoxinA for a mean of 9.1±2.9 years (range, 5.0 to 16.8 years). Data were collected from 5112 treatment sessions; 4402 included GL treatment. Mean age at first injection was 46.3±9.9 years. The longer patients were treated, the younger they perceived themselves to look. GL treatment temporally preceded crow’s feet lines (CFL), followed by forehead lines (FHL). Dosing in GL and CFL remained relatively stable from 1999 to 2012, although FHL dose decreased. Most patients (85%; 165/194) received treatment with fillers, of which 111 began, on average, 38 months after first onabotulinumtoxinA treatment. The rest had received fillers previously (n¼25) or began in the same year (n¼29). Besides a cumulative increase in onabotulinumtoxinA treatments in GL, FHL, and CFL over time, there were increases in facial aesthetic treatments with injectable fillers, energy-based devices, and prescription topical creams. Adverse events were infrequent, mostly mild in severity, and declined markedly over the first year of treatment. Conclusions: Continuous onabotulinumtoxinA treatments over several years are safe and can be used in conjunction with other aesthetic treatments. Patients receiving continuous onabotulinumtoxinA treatment perceived themselves to look younger than their actual age. Keywords: Botulinum neurotoxin type A; Crow’s feet lines; FLSQ; Forehead lines; Glabellar lines; OnabotulinumtoxinA; Patient-reported outcomes; Patient satisfaction 42. LONG-LASTING FUNCTIONAL BRAIN CHANGES IN A CASE STUDY OF CERVICAL DYSTONIA TREATED WITH BOTULINUM TOXIN AND MOTOR RELEARNING TECHNIQUES A. Castagna*, F. Baglio, M. Ramella, O. Di Pasquale, A. Marzegan, A. Crippa, G. Giacobbi, J. Jonsdottir, A. Montesano IRCCS Don Carlo Gnocchi Foundation, Milan, Italy *Corresponding author: IRCCS Don Carlo Gnocchi Foundation, Via Capecelatro 66, Milan, Italy 20100, Italy. E-mail address: [email protected]
Introduction and Objectives: CD is characterized by involuntary, abnormal movements and postures of the head and neck. Current views on its pathophysiology are faulty sensorimotor integration and impaired motor planning. Efficacy of BoNT has been demonstrated, and there are