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33 results on '"Gasalla, Teresa"'

6. Efficacy of Rozanolixizumab in Generalized Myasthenia Gravis: Subgroup Analyses from the Randomized Phase 3 MycarinG Study (S5.007)

Author

Vu, Tuan, primary, Drużdż, Artur, additional, Grosskreutz, Julian, additional, Habib, Ali A., additional, Kaminski, Henry J., additional, Mantegazza, Renato, additional, Utsugisawa, Kimiaki, additional, Vissing, John, additional, Beau-Lejdstrom, Raphaelle, additional, Boehnlein, Marion, additional, Gasalla, Teresa, additional, Grimson, Fiona, additional, Tarancón, Thaïs, additional, and Bril, Vera, additional

Published
2023
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16. A review of the pharmacology and clinical efficacy of brivaracetam

Author

Klein,Pavel, Diaz,Anyzeila, Gasalla,Teresa, and Whitesides,John

Subjects
Advances and Applications [Clinical Pharmacology]
Abstract

Pavel Klein,1 Anyzeila Diaz,2 Teresa Gasalla,3 John Whitesides4 1Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA; 2Neurology Patient Value Unit, UCB Pharma, Smyrna, GA, USA; 3Neurology Patient Value Unit, UCB Pharma, Monheim am Rhein, Germany; 4Asset Development, UCB Pharma, Raleigh, NC, USA Abstract: Brivaracetam (BRV; Briviact) is a new antiepileptic drug (AED) approved for adjunctive treatment of focal (partial-onset) seizures in adults. BRV is a selective, high-affinity ligand for synaptic vesicle 2A (SV2A) with 15- to 30-fold higher affinity than levetiracetam, the first AED acting on SV2A. It has high lipid solubility and rapid brain penetration, with engagement of the target molecule, SV2A, within minutes of administration. BRV has potent broad-spectrum antiepileptic activity in animal models. Phase I studies indicated BRV was well tolerated and showed a favorable pharmacokinetic profile over a wide dose range following single (10–1,000 mg) and multiple (200–800 mg/day) oral dosing. Three pivotal Phase III studies have demonstrated promising efficacy and a good safety and tolerability profile across doses of 50–200 mg/day in the adjunctive treatment of refractory focal seizures. Long-term data indicate that the response to BRV is sustained, with good tolerability and retention rate. BRV is highly effective in patients experiencing secondarily generalized tonic–clonic seizures. Safety data to date suggest a favorable psychiatric adverse effect profile in controlled studies, although limited postmarketing data are available. BRV is easy to use, with no titration and little drug–drug interaction. It can be initiated at target dose with no titration. Efficacy is seen on day 1 of oral use in a significant percentage of patients. Intravenous administration in a 2-minute bolus and 15-minute infusion is well tolerated. Here, we review the pharmacology, pharmacokinetics, and clinical data of BRV. Keywords: brivaracetam, efficacy, epilepsy, focal seizures, pharmacokinetics, tolerability

Published
2018

20. Cerebrospinal Fluid Nitrate Levels in Patients with Multiple Sclerosis

Author

de Bustos, Fernando, primary, Navarro, José Antonio, additional, de Andrés, Clara, additional, Molina, José Antonio, additional, Jiménez-Jiménez, Félix Javier, additional, Ortí-Pareja, Miguel, additional, Gasalla, Teresa, additional, Tallón-Barranco, Antonio, additional, Martínez-Salio, Antonio, additional, and Arenas, Joaquín, additional

Published
1999
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21. Bilateral primary writing tremor

Author

Jimenez-Jimenez, Felix J., primary, Cabrera-Valdivia, Francisco, additional, Orti-Pareja, Miguel, additional, Gasalla, Teresa, additional, Tallon-Barranco, Antonio, additional, and Zurdo, Martin, additional

Published
1998
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23. Cerebrospinal fluid levels of alpha-tocopherol in patients with multiple sclerosis

Author

Jiménez-Jiménez, Felix Javier, primary, de Bustos, Fernando, additional, Molina, José Antonio, additional, de Andrés, Clara, additional, Gasalla, Teresa, additional, Ortı́-Pareja, Miguel, additional, Zurdo, Martı́n, additional, Porta, Jesús, additional, Castellano-Millán, Francisca, additional, Arenas, Joaquı́n, additional, and de Salamanca, Rafael Enrı́quez, additional

Published
1998
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25. Acoustic voice analysis in patients with essential tremor

Author

Gamboa, Javier, primary, Jiménez-Jiménez, Félix Javier, additional, Nieto, Alberto, additional, Cobeta, Ignacio, additional, Vegas, Alberto, additional, Ortí-Pareja, Miguel, additional, Gasalla, Teresa, additional, Molina, José Antonio, additional, and García-Albea, Esteban, additional

Published
1998
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31. Combined Assessment of Function and Survival to Demonstrate the Effect of Treatment on Progressive Supranuclear Palsy.

Author

Germani, Massimiliano, Rebollo Mesa, Irene, Buchanan, Tim J., De Bruyn, Steven, Gasalla, Teresa, Van Tricht, Hans Lieve G., Ewen, Colin, Golbe, Lawrence I., Boxer, Adam, and Höglinger, Günter

Subjects
*PROGRESSIVE supranuclear palsy, *TREATMENT effectiveness, *ITEM response theory, *CLINICAL trials, *TREATMENT duration
Abstract

Background Objective Methods Results Conclusions Progressive supranuclear palsy (PSP) is a rare and fatal neurodegenerative disorder for which there are currently no disease‐modifying treatments. Recent trials of potential therapies had durations of 12 months, which may be insufficient because of nonrandom missingness due to death. Longer durations, incorporating PSP Rating Scale and survival, can reduce the potential for type II error. Selecting efficacy measures more sensitive to disease modification may facilitate identification of treatment effect.The objective of this study was to evaluate the simulated phase 3 PSP trial assessing the effect of disease‐modifying intervention on a novel combined primary endpoint comprising function (PSP Rating Scale) and survival, the Combined Assessment of Function and Survival (CAFS), and to determine operating characteristics of the CAFS.To simulate PSP progression in the trial population, we developed models of PSP Rating Scale and survival using data from published clinical studies. These models were used to define operating characteristics of the CAFS for use in a phase 3 trial.The sample size determined (N = 384; 1:1 randomization) would provide >80% power to detect significant treatment effects on the CAFS compared with placebo. The CAFS provides good operating characteristics and increased power to detect moderate treatment effects on the PSP Rating Scale. We propose a trial design allowing potential detection of treatment effects at a preplanned interim analysis after participants complete 12 months of treatment, with assessment of effects of treatment (≤24 months) on survival.Use of the CAFS could provide a comprehensive and robust estimate of the clinical benefit of future therapies. © 2024 UCB. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Published
2024
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33. A review of the pharmacology and clinical efficacy of brivaracetam.

Author

Klein P, Diaz A, Gasalla T, and Whitesides J

Abstract

Brivaracetam (BRV; Briviact) is a new antiepileptic drug (AED) approved for adjunctive treatment of focal (partial-onset) seizures in adults. BRV is a selective, high-affinity ligand for synaptic vesicle 2A (SV2A) with 15- to 30-fold higher affinity than levetiracetam, the first AED acting on SV2A. It has high lipid solubility and rapid brain penetration, with engagement of the target molecule, SV2A, within minutes of administration. BRV has potent broad-spectrum antiepileptic activity in animal models. Phase I studies indicated BRV was well tolerated and showed a favorable pharmacokinetic profile over a wide dose range following single (10-1,000 mg) and multiple (200-800 mg/day) oral dosing. Three pivotal Phase III studies have demonstrated promising efficacy and a good safety and tolerability profile across doses of 50-200 mg/day in the adjunctive treatment of refractory focal seizures. Long-term data indicate that the response to BRV is sustained, with good tolerability and retention rate. BRV is highly effective in patients experiencing secondarily generalized tonic-clonic seizures. Safety data to date suggest a favorable psychiatric adverse effect profile in controlled studies, although limited postmarketing data are available. BRV is easy to use, with no titration and little drug-drug interaction. It can be initiated at target dose with no titration. Efficacy is seen on day 1 of oral use in a significant percentage of patients. Intravenous administration in a 2-minute bolus and 15-minute infusion is well tolerated. Here, we review the pharmacology, pharmacokinetics, and clinical data of BRV., Competing Interests: Disclosure PK has served as a consultant for Eisai, Lundbeck, Sunovion, and UCB Pharma, is on the speakers bureaux for Eisai, Sunovion, and UCB Pharma, and has received grant support from Eisai and Lundbeck. AD, TG, and JW are employees of UCB Pharma. The authors report no other conflicts of interest in this work.

Published
2018
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