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DaxibotulinumtoxinA for Injection in Adults with Cervical Dystonia: Clinical Insights from a Real-World Early Experience Program.
[BACKGROUND] DaxibotulinumtoxinA for injection (DAXI), a novel botulinum toxin (BoNT) formulated with a custom-engineered peptide, was recently approved for treating cervical dystonia (CD). DAXI demonstrated a long duration of symptom relie…
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Botulinum toxin use in patients with neurological disorders: A U.S.-based claims database analysis.
[BACKGROUND AND OBJECTIVE] Real-world evidence describing long-term persistency with botulinum toxin (BoNT) therapy is limited. We assessed treatment patterns and persistency with BoNT in clinical practice over 2 years. [DESIGN] Retrospect…
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A randomized, double-blind, placebo-controlled trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury.
[BACKGROUND] Intramuscular injection of botulinum toxin type A is a first-line pharmacotherapy for adults with upper limb spasticity (ULS). However, reemergence of symptoms within 12 weeks of treatment is common and longer-lasting treatment…
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Efficacy Remaining at Time of Requested Re-Treatment for Cervical Dystonia: A Potential New Treatment Paradigm with DaxibotulinumtoxinA.
The therapeutic efficacy remaining from prior treatments with botulinum toxins (BoNTs) when cervical dystonia (CD) patients prefer to be re-treated has not been well characterized. Here, we assessed the residual therapeutic efficacy of BoNT…
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Efficacy and safety of DaxibotulinumtoxinA for injection in adults with cervical dystonia: Pooled global analysis of ASPEN-1 and ASPEN-1-CN randomized trials.
[BACKGROUND] DaxibotulinumtoxinA for injection (DAXI), the first long-acting botulinum toxin (BoNT) type A, is FDA approved for cervical dystonia (CD). DAXI's novel formulation, which includes a custom-engineered peptide, is designed to pro…
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Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia: ASPEN-1 Phase 3 Randomized Controlled Trial.
[BACKGROUND AND OBJECTIVES] ASPEN-1 was a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, duration of response, and safety of 2 doses of DaxibotulinumtoxinA for Injection (DAXI), a novel botulinum toxin…
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Improvement in Quality-of-Life-Related Outcomes Following Treatment with IncobotulinumtoxinA in Adults with Limb Spasticity: A Pooled Analysis.
A strong correlation has been reported between patient-reported quality of life (QoL) and the investigator-rated Disability Assessment Scale (DAS) in patients with spasticity. The current analysis evaluates the effect of incobotulinumtoxinA…
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Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study.
Cervical dystonia (CD) is primarily treated with botulinum toxin, at intervals of ≥ 12 weeks. We present efficacy, patient-reported outcomes (PROs), and safety in adults with CD at the last available visit after a single set of abobotulinum…
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AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol.
[INTRODUCTION] The safety and efficacy of both abobotulinumtoxinA and onabotulinumtoxinA for upper limb spasticity are well established, but head-to-head comparisons are lacking. [METHODS] DIRECTION is an international, randomized, double-…
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Comparison of Phasix, polypropylene, and primary closure of the abdominal donor site after bilateral free flap breast reconstruction: Long-term evaluation of abdominal hernia and bulge formation.
[BACKGROUND] Abdominal free flap harvest for breast reconstruction may result in significant morbidity in terms of hernias and bulges. Reinforcement of the donor site with mesh has been recommended to minimize the risk of hernias and bulges…
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Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study.
[BACKGROUND] Injectable daxibotulinumtoxinA (an investigational botulinum toxin, RT002) may offer a more prolonged duration of response-and therefore less frequent dosing-than onabotulinumtoxinA. [OBJECTIVES] To perform a phase 2, open-lab…
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Spasticity Video Challenge: A Look at Methods for Addressing Difficult Cases.
As seen in this CME online activity (available at http://courses.elseviercme.com/spasticity/662e), treatment of patients with spasticity due to upper motor neuron syndromes, including traumatic brain injury, stroke, and cerebral palsy, is m…
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Neck Pain and Cervical Dystonia: Treatment Outcomes from CD PROBE (Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy).
[BACKGROUND] Pain is a prevailing feature of cervical dystonia (CD), the most common form of focal dystonia. This analysis examined pain relief after onabotulinumtoxinA treatment in CD subjects with moderate/severe pain from the Cervical Dy…