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Considerations for determining the efficacy of new antiseizure medications in children age 1 month to younger than 2 years

Autor: Jacqueline A. French, Elena Cleary, Dennis Dlugos, Gail Farfel, Kathleen Farrell, Barry Gidal, Caitlin L. Grzeskowiak, Rachel Gurrell, Cynthia Harden, Tracy J. Stalvey, Julia Tsai, Elaine C. Wirrell, David Blum, Nathan Fountain

Publikováno v: Epilepsia. 63:2664-2670

Drug treatment for children with epilepsy should, ideally, be governed by evidence from adequate and well-controlled clinical studies. However, these studies are difficult to conduct, and so direct evidence supporting the informed use of specific dru

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::459eca2cf7adb51471429476cf52ba5d
https://doi.org/10.1111/epi.17366

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Fenfluramine treatment is associated with improvement in everyday executive function in preschool-aged children (5 years) with Dravet syndrome: A critical period for early neurodevelopment

Autor: Kim I. Bishop, Peter K. Isquith, Gerard A. Gioia, Kelly G. Knupp, Ingrid E. Scheffer, Rima Nabbout, Nicola Specchio, Joseph Sullivan, Stéphane Auvin, J. Helen Cross, Renzo Guerrini, Gail Farfel, Bradley S. Galer, Arnold R. Gammaitoni

Publikováno v: Epilepsybehavior : EB. 138

To evaluate whether fenfluramine (FFA) is associated with improvement in everyday executive function (EF)-self-regulation-in preschool-aged children with Dravet syndrome (DS).Children with DS received placebo or FFA in one of two phase III studies (f

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::de2f7ab2fdda5badeec84cbbcd0319a7
https://pubmed.ncbi.nlm.nih.gov/36463826

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Cardiovascular safety of fenfluramine in the treatment of Dravet syndrome: Analysis of an ongoing long‐term open‐label safety extension study

Autor: Wyman W. Lai, Milka Pringsheim, Anupam Agarwal, Pierre C. Wong, Bradley S. Galer, Gail Farfel, Martin G. Keane

Publikováno v: Epilepsia

Objective Fenfluramine, which was previously approved as a weight loss drug, was withdrawn in 1997 when reports of cardiac valvulopathy emerged. The present study was conducted in part to characterize the cardiovascular safety profile of low‐dose f

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1d61a350b28e0e38b99861e5813145b3
https://doi.org/10.1111/epi.16638

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Fenfluramine modulates the anti-amnesic effects induced by sigma-1 receptor agonists and neuro(active)steroids in vivo

Autor: Parthena Martin, Tangui Maurice, Arnold Gammaitoni, Gail Farfel, Brooks Boyd, Bradley Galer

Publikováno v: Epilepsybehavior : EB. 127

Fenfluramine (N-ethyl-α-methl-3-(trifluoromethyl)phenethylamine) is an anti-seizure medication (ASM) particularly effective in patients with Dravet syndrome, a severe treatment-resistant epileptic encephalopathy. Fenfluramine acts not only as neuron

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::074f016012f72fcea98b3abc438f4845
https://pubmed.ncbi.nlm.nih.gov/35007961

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A phase I, randomized, open-label, single-dose, 3-period crossover study to evaluate the drug-drug interaction between ZX008 (fenfluramine HCl oral solution) and a regimen of stiripentol, clobazam, and valproate in healthy subjects

Autor: Bradley S. Galer, Arnold R. Gammaitoni, Gail Farfel, Steven M. Smith, Boyd Brooks M

Publikováno v: International Journal of Clinical Pharmacology and Therapeutics

Objective Phase I, open-label, randomized, single-dose, 3-period crossover study assessing pharmacokinetics (PK) and safety of ZX008, a liquid oral formulation of fenfluramine (FFA) under development for adjunctive treatment of Dravet syndrome and Le

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ecaaad4242ef1a3d3204bf2e1bd2e6dc
https://doi.org/10.5414/cp203276

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Improved everyday executive functioning following profound reduction in seizure frequency with fenfluramine: Analysis from a phase 3 long-term extension study in children/young adults with Dravet syndrome

Autor: Bradley S. Galer, Rima Nabbout, Elaine C. Wirrell, Kim I. Bishop, Peter K. Isquith, Arnold R. Gammaitoni, Joseph Sullivan, Gerard A. Gioia, Gail Farfel, Tilman Polster

Publikováno v: Epilepsybehavior : EB. 121

Individuals with Dravet syndrome (DS) experience frequent pharmacoresistant seizures beginning in infancy. Most exhibit poor neurodevelopmental outcomes including motor function difficulties, behavior problems, and cognitive impairment. Cognitive def

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::49491ce80b7bfb51f5c134af3a7bd268
https://pubmed.ncbi.nlm.nih.gov/34023810

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Treatment with fenfluramine in patients with Dravet syndrome has no long-term effects on weight and growth

Autor: M. Scott Perry, Bradley S. Galer, Kelly G. Knupp, Michael Lock, Rima Nabbout, Berten Ceulemans, Anupam Agarwal, Elaine C. Wirrell, Joseph Sullivan, Robert M. Cortes, Antonio Gil-Nagel, Orrin Devinsky, Ronald Davis, Arnold R. Gammaiton, Gail Farfel, Tilman Polster

Publikováno v: Epilepsy and behavior

Objective: Appetite disturbance and growth abnormalities are commonly reported in children with Dravet syndrome (DS). Fenfluramine (Fintepla) has demonstrated profound reduction in convulsive seizure frequency in DS and was recently approved for use

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bd20f48759345d60a0e7a651c36b7488
https://repository.uantwerpen.be/docstore/d:irua:8656

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