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Adjunctive perampanel for refractory partial-onset seizures: Randomized phase III study 304
Open accessAbstract
OBJECTIVE: To assess efficacy and safety of once-daily 8 or 12 mg perampanel, a noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid (AMPA) receptor antagonist, when added to concomitant antiepileptic drugs (AEDs) in the treatment of drug-resistant partial-onset seizures. METHODS: This was a multicenter, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT00699972). Patients (≥12 years, with ongoing seizures despite 1-3 AEDs) were randomized (1:1:1) to once-daily perampanel 8 mg, 12 mg, or placebo. Following baseline (6 weeks), patients entered a 19-week double-blind phase: 6-week titration (2 mg/week increments to target dose) followed by a 13-week maintenance period. Percent change in seizure frequency was the primary endpoint; 50% responder rate was the primary endpoint for EU registration. RESULTS: Of 388 patients randomized and treated, 387 provided seizure frequency data. Using this intent-to-treat population over the double-blind phase, the median percent change in seizure frequency was -21.0%, -26.3%, and -34.5% for placebo and perampanel 8 and 12 mg, respectively (p = 0.0261 and p = 0.0158 for 8 and 12 mg vs placebo, respectively). Fifty percent responder rates during the maintenance period were 26.4%, 37.6%, and 36.1%, respectively, for placebo, perampanel 8 mg, and perampanel 12 mg; these differences were not statistically significant for 8 mg (p = 0.0760) or 12 mg (p = 0.0914). Sixty-eight (17.5%) patients discontinued, including 40 (10.3%) for adverse events. Most frequent treatment-emergent adverse events were dizziness, somnolence, irritability, headache, fall, and ataxia. CONCLUSIONS: This trial demonstrated that once-daily, adjunctive perampanel at doses of 8 or 12 mg improved seizure control in patients with uncontrolled partial-onset seizures. Doses of perampanel 8 and 12 mg were safe, and tolerability was acceptable. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that once-daily 8 and 12 mg doses of adjunctive perampanel are effective in patients with uncontrolled partial-onset seizures.
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Cited by
French, J. A., Lawson, J. A., Yapici, Z., Ikeda, H., Polster, T., Nabbout, R., Curatolo, P., de Vries, P. J., Dlugos, D. J., Berkowitz, N., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(16)31419-2 · Cited by 764
Self-citationPerampanel for tonic-clonic seizures in idiopathic generalized epilepsy: A randomized trial
French, J. A., Krauss, G. L., Wechsler, R. T., Wang, X.-F., DiVentura, B., Brandt, C., Trinka, E., O'Brien, T. J., Laurenza, A., Patten, A., et al. (2015) · Neurology · doi:10.1212/wnl.0000000000001930 · Cited by 329
Self-citationThe Pharmacoresistant Epilepsy: An Overview on Existent and New Emerging Therapies
Fattorusso, A., Matricardi, S., Mencaroni, E., Dell'Isola, G. B., Di Cara, G., Striano, P., & Verrotti, A. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.674483 · Cited by 269
Orosz, I., McCormick, D., Zamponi, N., Varadkar, S., Feucht, M., Parain, D., Griens, R., Vallée, L., Boon, P., Rittey, C., et al. (2014) · Epilepsia · doi:10.1111/epi.12762 · Cited by 269
Biton, V., Berkovic, S. F., Abou‐Khalil, B., Sperling, M. R., Johnson, M. E., & Lu, S. (2014) · Epilepsia · doi:10.1111/epi.12433 · Cited by 253
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Metadata
- Authors
- French, J. A., Krauss, G. L., Biton, V., Squillacote, D., Yang, H., Laurenza, A., Kumar, D., Rogawski, M. A., Campanille, V., Floridia, J., Ilari, R., Consalvo, D. E., Thomson, A., Sfaello, I., Pociecha, J., Nieto, F., Firstenfeld, A., Zuin, D., Mesri, J., Silva, W., Nofal, P., Cristalli, D., Clement, J.-F., Hwang, P., McLachlan, R., Pillay, N., Lasso, J., Peralta, B. L., Hernandez, M. L., Tenhamm, E., Barroso, N., Milian, A. C., Morales, S. R., Rodríguez, I., Jain, S., Wilfong, A., Kalra, A., Renfroe, B., Moore, D., Flamini, J., Klapper, J., Szaflarski, J., Teasley, J., Halford, J., Ferreira, J., Goodpasture, H., Sperling, M., Klein, P., Ayala, R., Brower, R., Leroy, R., Davis, R., Elterman, R., Enlow, T., Sosa, V., Puri, V., Miller, J., Shneker, B., Bautista, R., Chung, S., Lesch, D., Steiner, D., Webb, R., Armstrong, R., Biton, V., Krauss, G., Mitchell, W., Hogan, R., Knowlton, R., Wheless, J., Aung-Din, R., Ali, I., Brown, L., Gruenthal, M., Kankirawatana, P., Charlet, M., Conry, J., Owen, M. B., Yerby, M., Herrman, C., Fessler, A., Modur, P., Miranda, F., & King-Stephens, D.
- Venue
- Neurology
- Published
- 2012-08-07
- Volume
- 79
- Issue
- 6
- Pages
- 589-596
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- OpenAlex
- W2135808877
- Cited by
- 479
- References
- 0
- FWCI
- 26.64
- Type
- journal article
- Language
- en
- Open access
- bronze
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- French, J. A., Krauss, G. L., Biton, V., Squillacote, D., Yang, H., Laurenza, A., Kumar, D., Rogawski, M. A., Campanille, V., Floridia, J., Ilari, R., Consalvo, D. E., Thomson, A., Sfaello, I., Pociecha, J., Nieto, F., Firstenfeld, A., Zuin, D., Mesri, J., . . . King-Stephens, D. (2012). Adjunctive perampanel for refractory partial-onset seizures: Randomized phase III study 304. Neurology. https://doi.org/10.1212/wnl.0b013e3182635735
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