Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Cindy, McShea"'
Publikováno v:
Pharmaceutical Statistics. 22:378-395
Sponsors have a responsibility to minimise risk to participants in clinical studies through safety monitoring. The FDA Final Rule for IND Safety Reporting requires routine aggregate safety evaluation, including in ongoing blinded studies. We are inte
Autor:
Anyzeila Diaz, Vincent Badalamenti, Teresa Gasalla, John Whitesides, Stephan Arnold, Cindy McShea, Toufic Fakhoury
Publikováno v:
Epilepsy Research. 141:73-82
Brivaracetam (BRV), a selective, high-affinity ligand for synaptic vesicle protein 2A, is a new antiepileptic drug (AED) approved for monotherapy (in the USA) and adjunctive treatment of focal (partial-onset) seizures in adults, at a dose range of 50
Autor:
William, Rosenfeld, Nathan B, Fountain, Gintaras, Kaubrys, Elinor, Ben-Menachem, Cindy, McShea, Jouko, Isojarvi, Pamela, Doty, Azita, Tofighy
Publikováno v:
Epilepsy & Behavior. 41:164-170
Long-term (up to 8 years of exposure) safety and efficacy of the antiepileptic drug lacosamide was evaluated in this open-label extension trial (SP615 [ClinicalTrials.gov identifier: NCT00552305]). Patients were enrolled following participation in a
Publikováno v:
Epilepsia. 53:521-528
Summary Purpose: To evaluate the long-term (up to 5 years exposure) safety and efficacy of lacosamide as adjunctive therapy in patients with uncontrolled partial-onset seizures taking one to three concomitant antiepileptic drugs (AEDs) in open-label
Publikováno v:
Epilepsy research. 120
This was an open-label study (N01281 [NCT00419393]) assessing the long-term safety of extended-release levetiracetam (LEV XR) in patients with partial-onset seizures (POS); the study was a follow-up to a double-blind, randomized, historical controlle
Publikováno v:
Epilepsia. 53(3)
To evaluate the long-term (up to 5 years exposure) safety and efficacy of lacosamide as adjunctive therapy in patients with uncontrolled partial-onset seizures taking one to three concomitant antiepileptic drugs (AEDs) in open-label extension trial S
Autor:
Gagik Avakyan, Sarah Lu, Steve Chung, Jimmy Schiemann, Jacek Gawłowicz, Cindy McShea, Hugo Ceja
Publikováno v:
Epilepsy research. 101(1-2)
Summary This double-blind, randomised, multicentre, conversion to monotherapy, historical control study (N01280; NCT00419094 ) evaluated the efficacy, safety and tolerability of levetiracetam extended release (LEV XR) 2000 mg/day once daily for the t
Autor:
Jouko Isojarvi, Pamela Doty, William E. Rosenfeld, Felix Rosenow, Aatif M. Husain, Cindy McShea
Publikováno v:
Neurology. 78:P06.125-P06.125
Objective: To evaluate open-label treatment with lacosamide, an antiepileptic drug (AED) for the adjunctive treatment of partial-onset seizures (POS) in adults, for up to 8 years in a pooled patient population. Background Epilepsy is a chronic condit