The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.
Multicenter Double‐Blind, Randomized, Placebo‐Controlled Trial of Levetiracetam as Add‐On Therapy in Patients with Refractory Partial Seizures
Abstract
Summary: Purpose: To evaluate the efficacy and tolerability of levetiracetam (LEV, Keppra) as add‐on therapy in patients with refractory partial seizures. Methods: In this European multicenter, double‐blind, randomized, placebo‐controlled trial, LEV (500 or 1,000 mg twice daily) was compared with placebo as add‐on therapy in 324 patients with uncontrolled simple or complex partial seizures, or both, with or without secondary generalization. After enrollment, three parallel groups were assessed during a baseline period of 8 or 12 weeks, followed by a 4‐week titration interval and a 12‐week evaluation period. Results: LEV significantly decreased partial seizure frequency compared with placebo. A reduction in seizure frequency of 50% occurred in 22.8% of patients in the 1,000‐mg group and 31.6% of patients in the 2,000‐mg group, compared with 10.4% of patients in the placebo group. Administration of LEV did not affect plasma concentrations of concomitant an‐tiepileptic drugs or alter vital signs or laboratory parameters. No significant difference in the incidence of adverse events was observed between treatment groups (70.8% for the 1,000‐mg group and 75.5% for the 2,000‐mg group), or between the LEV and placebo groups (73.2% for placebo group). The most commonly reported adverse effects in the LEV group were asthenia, headache, and somnolence. Conclusions: The antiepileptic efficacy and tolerability of LEV (1,000 mg/d and 2,000 mg/d, administered in two divided doses) as add‐on therapy was established in patients with refractory partial seizures in this clinical study.
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Cites
The number needed to treat: a clinically useful measure of treatment effect
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Pharmacokinetic profile of levetiracetam
Patsalos, P. N. (2000) · Pharmacology & Therapeutics · doi:10.1016/s0163-7258(99)00052-2 · Cited by 519
Evidence for a unique profile of levetiracetam in rodent models of seizures and epilepsy
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Löscher, W., Hönack, D., & Rundfeldt, C. (1998) · The Journal of Pharmacology and Experimental Therapeutics · doi:10.1016/s0022-3565(24)37251-9 · Cited by 343
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In Vitro Evaluation of Potential Drug Interactions With Levetiracetam, A New Antiepileptic Agent
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Cited by
Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy
Brodie, M. J., Perucca, E., Ryvlin, P., Ben-Menachem, E., & Meencke, H.-J. (2007) · Neurology · doi:10.1212/01.wnl.0000252941.50833.4a · Cited by 467
Levetiracetam Mechanisms of Action: From Molecules to Systems
Contreras-García, I. J., Cárdenas-Rodríguez, N., Romo-Mancillas, A., Bandala, C., Zamudio, S. R., Gómez-Manzo, S., Hernández-Ochoa, B., Mendoza-Torreblanca, J. G., & Pichardo-Macías, L. A. (2022) · Pharmaceuticals · doi:10.3390/ph15040475 · Cited by 131
Trinka, E., Marson, A. G., Van Paesschen, W., Kälviäinen, R., Marovac, J., Duncan, B., Buyle, S., Hallström, Y., Hon, P., Muscas, G. C., et al. (2013) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp-2011-300376 · Cited by 121
Self-citationLevetiracetam and brivaracetam: A review of evidence from clinical trials and clinical experience
Steinhoff, B. J., & Staack, A. M. (2019) · Therapeutic Advances in Neurological Disorders · doi:10.1177/1756286419873518 · Cited by 99
Wu, P.-P., Cao, B.-R., Tian, F.-Y., & Gao, Z.-B. (2024) · Neuroscience Bulletin · doi:10.1007/s12264-023-01138-2 · Cited by 35
Metadata
- Authors
- Shorvon, S. D., Löwenthal, A., Janz, D., Bielen, E., Loiseau, P., & for the European Levetiracetam Study Group
- Venue
- Epilepsia
- Publisher
- Wiley
- Published
- 2000-09
- Volume
- 41
- Issue
- 9
- Pages
- 1179-1186
- ISSN
- 0013-9580 (ISSN-L)
- 1528-1167
- OpenAlex
- W1979558709
- Cited by
- 451
- References
- 10
- FWCI
- 19.38
- Type
- journal article
- Language
- en
- Open access
- closed
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- Shorvon, S. D., Löwenthal, A., Janz, D., Bielen, E., Loiseau, P., & for the European Levetiracetam Study Group. (2000). Multicenter Double‐Blind, Randomized, Placebo‐Controlled Trial of Levetiracetam as Add‐On Therapy in Patients with Refractory Partial Seizures. Epilepsia. https://doi.org/10.1111/j.1528-1157.2000.tb00323.x
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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