Showing 1991-2000 of 2105 results for "".
- FDA Approves Expanded Indication for AbobotulinumtoxinA—Upper Limb Spasticity in Children Age 2 or Morehttps://practicalneurology.com/news/fda-approves-expanded-indication-for-abobotulinumtoxinaupper-limb-spasticity-in-children-age-2-or-more/2469033/The Food and Drug Administration (FDA) has approved expanded indications for abobotulinumtoxinA (Dysport; Ipsen Group, Cambridge, MA) to include treatment of upper limb spasticity in children age 2 years or more, excluding spasticity caused by cerebral palsy (CP). With this approval, abobotulinum
- Soticlestat Reduces Seizure Frequency in Developmental and Epileptic Encephalopathies in Phase 2 Trialhttps://practicalneurology.com/news/soticlestat-reduces-seizure-frequency-in-developmental-and-epileptic-encephalopathies-in-phase-2-trial/2469032/Initial findings of the ENDYMION trial (NCT03635073) suggest soticlestat (OV935/TAK935; Ovid Therapeutics, New York, NY) reduces the frequency of seizures in people with rare developmental and epileptic encephalopathies (DEE), includin
- Fenfluramine, Antiseizure Medication With Durable Profound Seizure Reduction to Be Resubmitted to FDA This Monthhttps://practicalneurology.com/news/fenfluramine-antiseizure-medication-with-durable-profound-seizure-reduction-to-be-resubmitted-to-fda-this-month/2469023/In clinical trials, treatment with low dose fenfluramine (Fintepla; Zogenix, Emeryville, CA) has resulted in large consistent durable reductions in seizure frequency for individuals with Dravet’s syndrome (DS). In 2 pivotal clinical trials, children age 2 to 18 years, who were treated with
- First Participant Enrolled in Phase 3 Trial of Gaboxadol for Angelman Syndromehttps://practicalneurology.com/news/first-participant-enrolled-in-phase-3-trial-of-gaboxadol-for-angelman-syndrome/2469019/The first participant has been enrolled and randomly assigned to a trial arm in the phase 3 NEPTUNE trial (NCT02996305) of gaboxadol (OV101; Ovid Therapeutics, New York, NY) for Angelman syndrome (AS). Approximately 60 childr
- Extended-Interval Dosing of Natalizumab Efficacy in Retrospective Propensity Score Analysis of Real-World Datahttps://practicalneurology.com/news/extended-interval-dosing-of-natalizumab-efficacy-in-retrospective-propensity-score-analysis-of-real-world-data/2469016/Using propensity score analysis in which individuals who had extended-interval dosing (EID) after at least 1 year of standard-interval dosing (SID) of natalizumab (Tysabri; Biogen, Cambridge, MA) were matched with individuals treated with standard-interval dosing (SID) for comparison of outcomes.
- Natalizumab Treatment Reduced Disability With No Cases of PML in Anti-JC-Virus Antibody Negative Multiple Sclerosishttps://practicalneurology.com/news/natalizumab-treatment-reduced-disability-with-no-cases-of-pml-in-anti-jc-virus-antibody-negative-multiple-sclerosis/2469010/In the STRIVE clinical trial (NCT01485003),4 years of treatment with natalizumab (Tysabri; Biogen, Cambridge, MA) reduced disability and annualized relapse rates (Table).
- First Participant Enrolled in Observational Study of Children and Teens With Dravet Syndromehttps://practicalneurology.com/news/first-participant-enrolled-in-observational-study-of-children-and-teens-with-dravet-syndrome-1/2468998/The first person has been enrolled in the BUTTERFLY observational study sponsored by Stoke Therapeutics (Bedford, MA). The BUTTERFLY study is a 2-year observationa
- Faster—and Free—Genetic Testing for Spinal Muscular Atrophyhttps://practicalneurology.com/news/fasterand-freegenetic-testing-for-spinal-muscular-atrophy/2468996/A new genetic test for spinal muscular atrophy (SMA) provides results in 4 days vs the 21 day wait previously needed. Early diagnosis is essential for early treatment, shown to slow disease progression, prolong survival by years, and improve or stabilize loss of motor function. Of note, the test
- Phase 1 Studies Begin for EPX-100 for Dravet’s Syndromehttps://practicalneurology.com/news/phase-1-studies-begin-for-epx-100-for-dravets-syndrome/2468983/The Food and Drug Administration has approved the Investigational New Drug Application for EPX-100 (Epygenix Therapeutics, Inc., Paramus, NJ), allowing a phase 1 study to being. This phase 1 placebo-controlled, 2-period study of EPX-100 will test safety and pharmacokinetics of escalating single a
- Phase 3 Trial of Fenfluramine for Lennox-Gastaut Syndrome Completes Enrollmenthttps://practicalneurology.com/news/phase-3-trial-of-fenfluramine-for-lennox-gastaut-syndrome-completes-enrollment/2468948/Enrollment of 263 individuals with Lennox-Gastaut syndrome (LGS) has been completed for a phase 3 clinical (NCT03355209) trial of fenfluramine (Fintepla; Zogenix, Emeryville, CA). The primary outcome measure is decreased seizure freque