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16. Efficacy of Cenobamate for Uncontrolled Focal Seizures: Post-hoc Analysis of a Phase 3, Multicenter, Open-Label Study (1777)

Author

Sperling, Michael R., primary, Abou-Khalil, Bassel, additional, Aboumatar, Sami, additional, Bhatia, Perminder, additional, Biton, Victor, additional, Klein, Pavel, additional, Krauss, Gregory L., additional, Vossler, David G., additional, Wechsler, Robert, additional, Ferrari, Louis, additional, Kamin, Marc, additional, Grall, Mindy, additional, and Rosenfeld, William E., additional

Published
2021
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18. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial

Author

Krauss, Gregory L., Krauss, Gregory L., Klein, Pavel, Brandt, Christian, Lee, Sang Kun, Milanov, Ivan, Milovanović, Maja, Steinhoff, Bernhard J., Kamin, Marc, Krauss, Gregory L., Krauss, Gregory L., Klein, Pavel, Brandt, Christian, Lee, Sang Kun, Milanov, Ivan, Milovanović, Maja, Steinhoff, Bernhard J., and Kamin, Marc

Abstract

Background More than a third of patients with epilepsy are treatment resistant, and thus new, more effective therapies to achieve seizure freedom are needed. Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spectrum anticonvulsant activity in preclinical studies and seizure models. We aimed to evaluate the safety, efficacy, and tolerability of adjunctive cenobainate in patients with uncontrolled focal (partial)-onset epilepsy. Methods We did a multicentre, double-blind, randomised, placebo-controlled, dose-response study at 107 epilepsy and neurology centres in 16 countries. Adult patients (aged 18-70 years) with focal seizures despite treatment with 1-3 antiepileptic drugs were randomly assigned (1:1:1:1) via an interactive web response system, by block sizes of 4 within each country, to adjuvant once daily oral cenobamate at dose groups of 100 mg, 200 mg, or 400 mg, or placebo following an 8-week baseline assessment. Patients, investigators, and study personnel were masked to treatment assignment. The study included a 6-week titration phase and 12-week maintenance phase. The primary efficacy outcomes were percentage change in 28-day focal seizure frequency (focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic seizures) from baseline analysed in the modified intention-to-treat population (>= 1 dose and any post-baseline seizure data) and responder rates (a50% reduction) analysed in the maintenance phase population (>= 1 dose in the maintenance phase and any maintenance phase seizure data). The primary efficacy outcomes were analysed using a hierarchal step-down procedure comparing 200 mg versus placebo, 400 mg versus placebo, then 100 mg versus placebo. Safety and tolerability were compared descriptively across treatment groups for all randomised patients. This study is registered with ClinicalTrials.gov, number NCT01866111. Findings Between July 31, 2013, and June 22,2015,437 patients were randomly assigned to

Published
2020

19. Effect of cenobamate on the single‐dose pharmacokinetics of multiple cytochrome P450 probes using a cocktail approach in healthy subjects.

Author

Greene, Stephen A., Kwak, Charles, Kamin, Marc, Vernillet, Laurent, Glenn, Kelli J., Gabriel, Lana, and Kim, Hong Wook

Subjects
OMEPRAZOLE, CYTOCHROME P-450, PHARMACOKINETICS, CYTOCHROME P-450 CYP2C19, MIDAZOLAM, SEIZURES (Medicine)
Abstract

This study was designed to evaluate the effects of cenobamate, an antiseizure medication for focal seizures, on the pharmacokinetics of cytochrome P450 probes (bupropion, CYP2B6; midazolam, CYP3A4/5; warfarin, CYP2C9; and omeprazole, CYP2C19) in healthy subjects. Probes were administered alone on days 1 (bupropion) and 7 (midazolam/warfarin/omeprazole), and with cenobamate 100 mg/day on day 69 (midazolam) and cenobamate 200 mg/day on days 99 (bupropion) and 105 (midazolam/warfarin/omeprazole). No significant interaction was concluded if 90% confidence intervals (CIs) for geometric mean ratios (GMRs) for area under the curve (AUC) and maximum concentration of CYP substrates and/or their metabolites were within the no‐effect interval (0.80–1.25). When co‐administered with cenobamate 100 mg/day, AUC from time of administration up to the time of the last quantifiable concentration (AUC0–last) GMR (90% CIs) for midazolam was 0.734 (0.647–0.832). When co‐administered with cenobamate 200 mg/day, AUC0–last GMRs (90% CI) for midazolam, bupropion, S‐warfarin, and omeprazole were 0.277 (0.238–0.323), 0.615 (0.522–0.724), 1.14 (1.10–1.18), and 2.07 (1.44–2.98), respectively. Co‐administration of cenobamate with midazolam and bupropion probes led to values that were outside and below the no effect boundary, indicating that cenobamate induces the CYP3A4/5 and CYP2B6 enzymes. Co‐administration of cenobamate led to omeprazole values which were outside and above the no‐effect boundary, but with high variability, suggesting that cenobamate may moderately inhibit CYP2C19 activity. No effect on CYP2C9 was observed with the cenobamate and warfarin combination. Co‐administration of cenobamate with these probes drugs was well‐tolerated. In this study, 200 mg/day cenobamate moderately induced CYP3A4/5 (dose‐dependently; 100 mg/day was a weak inducer), was a weak inducer of CYP2B6, moderately inhibited CYP2C19, and had a negligible effect on CYP2C9. [ABSTRACT FROM AUTHOR]

Published
2022
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22. Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, open‐label safety study

Author

Sperling, Michael R., primary, Klein, Pavel, additional, Aboumatar, Sami, additional, Gelfand, Michael, additional, Halford, Jonathan J., additional, Krauss, Gregory L., additional, Rosenfeld, William E., additional, Vossler, David G., additional, Wechsler, Robert, additional, Borchert, Leona, additional, and Kamin, Marc, additional

Published
2020
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30. Initiation of epoetin-(alpha) therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy: an open-label, multicenter study with randomized and nonrandomized treatment arms

Author

Glaspy, John A., Charu, Veena, Luo, Donghan, Moyo, Victor, Kamin, Marc, and Wilhelm, Francois E.

Subjects
Erythropoietin, Recombinant -- Dosage and administration, Erythropoietin, Recombinant -- Research, Chemotherapy -- Complications and side effects, Chemotherapy -- Research, Anemia -- Care and treatment, Anemia -- Research, Cancer -- Chemotherapy, Cancer -- Complications and side effects, Cancer -- Research, Health
Published
2009

40. Letter

Author

Kamin, Marc, Cazzaniga, Ellen Kent, Raina, Maharaj K., and Shank, Richard P.

Published
1998

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