Long-term tolerability, safety and efficacy of adjunctive perampanel in the open-label, dose-ascending Study 231 and extension Study 233 in Japanese patients with epilepsy
•Studies 231/233 assessed perampanel tolerability in Japanese patients with POS.•33.3% of patients completing Study 231 achieved a maximum tolerated dose of 12 mg.•Median percent change in seizure frequency was –35.0% during Study 231.•In extension Study 233, 42.9% of patients received perampanel fo...
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| Veröffentlicht in: | Seizure (London, England) England), 2018-11, Vol.62, p.26-32 |
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| creator | Usui, Naotaka Akamatsu, Naoki Nakasato, Nobukazu Ohnishi, Akihiro Kaneko, Sunao Hiramatsu, Hidetaka Saeki, Kazunori Miyagishi, Hideaki Inoue, Yushi |
| description | •Studies 231/233 assessed perampanel tolerability in Japanese patients with POS.•33.3% of patients completing Study 231 achieved a maximum tolerated dose of 12 mg.•Median percent change in seizure frequency was –35.0% during Study 231.•In extension Study 233, 42.9% of patients received perampanel for ≤208 weeks.•Most treatment-related TEAEs were mild to moderate.
To evaluate long-term tolerability, safety and efficacy of adjunctive perampanel in a Phase II, multicentre, open-label, dose-ascending Study 231 (NCT00849212) and its extension (Study 233; NCT00903786) in Japanese patients with refractory partial-onset seizures (POS), with/without secondarily generalised seizures.
In Study 231, patients received adjunctive perampanel ≤12 mg/day during a 10-week treatment period. Patients completing Study 231 could enter Study 233 (≤316-week treatment period). Assessments included monitoring of treatment-related treatment-emergent adverse events (TEAEs), median percent change in seizure frequency per 28 days, 50% responder and seizure-freedom rates. During Study 231, a pharmacokinetic analysis assessed the effects of enzyme-inducing antiepileptic drugs.
Overall, 23/30 (76.7%) patients completed Study 231; 21/30 (70.0%) received perampanel ≥8 mg/day and 10/30 (33.3%) achieved a maximum tolerated dose of 12 mg/day. Median percent change in seizure frequency per 28 days was –35.0%. 50% responder rate was 37.0%; 4 (13.3%) patients achieved seizure freedom. Twenty-one patients entered Study 233. Mean duration of exposure was 195 weeks; 9 (42.9%) patients received perampanel for ≤208 weeks. Seizure control was sustained for 316 weeks in 3/21 (14.3%) patients; 2 achieved seizure freedom. Treatment-related TEAEs were tolerable; the most common was dizziness (Study 231, 53.3%; Study 233, 14.3%). Mean perampanel plasma concentrations were lower with concomitant carbamazepine vs non-inducers (152.7 ng/mL vs 389.4 ng/mL across perampanel groups); small patient numbers for non-inducers (n = 2) should be considered when interpreting these data.
Adjunctive perampanel demonstrated a favourable safety profile and long-term tolerability in Japanese patients with refractory POS for ≤316 weeks. |
| doi_str_mv | 10.1016/j.seizure.2018.09.012 |
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To evaluate long-term tolerability, safety and efficacy of adjunctive perampanel in a Phase II, multicentre, open-label, dose-ascending Study 231 (NCT00849212) and its extension (Study 233; NCT00903786) in Japanese patients with refractory partial-onset seizures (POS), with/without secondarily generalised seizures.
In Study 231, patients received adjunctive perampanel ≤12 mg/day during a 10-week treatment period. Patients completing Study 231 could enter Study 233 (≤316-week treatment period). Assessments included monitoring of treatment-related treatment-emergent adverse events (TEAEs), median percent change in seizure frequency per 28 days, 50% responder and seizure-freedom rates. During Study 231, a pharmacokinetic analysis assessed the effects of enzyme-inducing antiepileptic drugs.
Overall, 23/30 (76.7%) patients completed Study 231; 21/30 (70.0%) received perampanel ≥8 mg/day and 10/30 (33.3%) achieved a maximum tolerated dose of 12 mg/day. Median percent change in seizure frequency per 28 days was –35.0%. 50% responder rate was 37.0%; 4 (13.3%) patients achieved seizure freedom. Twenty-one patients entered Study 233. Mean duration of exposure was 195 weeks; 9 (42.9%) patients received perampanel for ≤208 weeks. Seizure control was sustained for 316 weeks in 3/21 (14.3%) patients; 2 achieved seizure freedom. Treatment-related TEAEs were tolerable; the most common was dizziness (Study 231, 53.3%; Study 233, 14.3%). Mean perampanel plasma concentrations were lower with concomitant carbamazepine vs non-inducers (152.7 ng/mL vs 389.4 ng/mL across perampanel groups); small patient numbers for non-inducers (n = 2) should be considered when interpreting these data.
Adjunctive perampanel demonstrated a favourable safety profile and long-term tolerability in Japanese patients with refractory POS for ≤316 weeks.</description><identifier>ISSN: 1059-1311</identifier><identifier>EISSN: 1532-2688</identifier><identifier>DOI: 10.1016/j.seizure.2018.09.012</identifier><identifier>PMID: 30267941</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; AMPA receptor ; Anticonvulsants - adverse effects ; Anticonvulsants - pharmacokinetics ; Anticonvulsants - therapeutic use ; Antiepileptic drugs ; Dose-Response Relationship, Drug ; Drug Therapy, Combination ; Drug Tolerance - physiology ; Epilepsy ; Epilepsy - drug therapy ; Female ; Humans ; Japan ; Longitudinal Studies ; Male ; Middle Aged ; Perampanel ; Pyridones - adverse effects ; Pyridones - pharmacokinetics ; Pyridones - therapeutic use ; Treatment Outcome ; Young Adult</subject><ispartof>Seizure (London, England), 2018-11, Vol.62, p.26-32</ispartof><rights>2018 The Authors</rights><rights>Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c412t-88156f58ad36e59f3771ad2b621868a019463e846ac28a36e213c4e4482c038a3</citedby><cites>FETCH-LOGICAL-c412t-88156f58ad36e59f3771ad2b621868a019463e846ac28a36e213c4e4482c038a3</cites><orcidid>0000-0001-8164-4171 ; 0000-0003-1331-7990</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.seizure.2018.09.012$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30267941$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Usui, Naotaka</creatorcontrib><creatorcontrib>Akamatsu, Naoki</creatorcontrib><creatorcontrib>Nakasato, Nobukazu</creatorcontrib><creatorcontrib>Ohnishi, Akihiro</creatorcontrib><creatorcontrib>Kaneko, Sunao</creatorcontrib><creatorcontrib>Hiramatsu, Hidetaka</creatorcontrib><creatorcontrib>Saeki, Kazunori</creatorcontrib><creatorcontrib>Miyagishi, Hideaki</creatorcontrib><creatorcontrib>Inoue, Yushi</creatorcontrib><title>Long-term tolerability, safety and efficacy of adjunctive perampanel in the open-label, dose-ascending Study 231 and extension Study 233 in Japanese patients with epilepsy</title><title>Seizure (London, England)</title><addtitle>Seizure</addtitle><description>•Studies 231/233 assessed perampanel tolerability in Japanese patients with POS.•33.3% of patients completing Study 231 achieved a maximum tolerated dose of 12 mg.•Median percent change in seizure frequency was –35.0% during Study 231.•In extension Study 233, 42.9% of patients received perampanel for ≤208 weeks.•Most treatment-related TEAEs were mild to moderate.
To evaluate long-term tolerability, safety and efficacy of adjunctive perampanel in a Phase II, multicentre, open-label, dose-ascending Study 231 (NCT00849212) and its extension (Study 233; NCT00903786) in Japanese patients with refractory partial-onset seizures (POS), with/without secondarily generalised seizures.
In Study 231, patients received adjunctive perampanel ≤12 mg/day during a 10-week treatment period. Patients completing Study 231 could enter Study 233 (≤316-week treatment period). Assessments included monitoring of treatment-related treatment-emergent adverse events (TEAEs), median percent change in seizure frequency per 28 days, 50% responder and seizure-freedom rates. During Study 231, a pharmacokinetic analysis assessed the effects of enzyme-inducing antiepileptic drugs.
Overall, 23/30 (76.7%) patients completed Study 231; 21/30 (70.0%) received perampanel ≥8 mg/day and 10/30 (33.3%) achieved a maximum tolerated dose of 12 mg/day. Median percent change in seizure frequency per 28 days was –35.0%. 50% responder rate was 37.0%; 4 (13.3%) patients achieved seizure freedom. Twenty-one patients entered Study 233. Mean duration of exposure was 195 weeks; 9 (42.9%) patients received perampanel for ≤208 weeks. Seizure control was sustained for 316 weeks in 3/21 (14.3%) patients; 2 achieved seizure freedom. Treatment-related TEAEs were tolerable; the most common was dizziness (Study 231, 53.3%; Study 233, 14.3%). Mean perampanel plasma concentrations were lower with concomitant carbamazepine vs non-inducers (152.7 ng/mL vs 389.4 ng/mL across perampanel groups); small patient numbers for non-inducers (n = 2) should be considered when interpreting these data.
Adjunctive perampanel demonstrated a favourable safety profile and long-term tolerability in Japanese patients with refractory POS for ≤316 weeks.</description><subject>Adult</subject><subject>AMPA receptor</subject><subject>Anticonvulsants - adverse effects</subject><subject>Anticonvulsants - pharmacokinetics</subject><subject>Anticonvulsants - therapeutic use</subject><subject>Antiepileptic drugs</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Therapy, Combination</subject><subject>Drug Tolerance - physiology</subject><subject>Epilepsy</subject><subject>Epilepsy - drug therapy</subject><subject>Female</subject><subject>Humans</subject><subject>Japan</subject><subject>Longitudinal Studies</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Perampanel</subject><subject>Pyridones - adverse effects</subject><subject>Pyridones - pharmacokinetics</subject><subject>Pyridones - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1059-1311</issn><issn>1532-2688</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc9u1DAQxi0EomXhEUA-cmiCx068zgmhir9aiQNwtrz2pPUqcYLtlIZX4iXxapdeOXk0-r5vZvwj5CWwGhjIN4c6of-9RKw5A1WzrmbAH5FLaAWvuFTqcalZ21UgAC7Is5QOjLGuAfGUXAjG5bbUl-TPbgo3VcY40jwNGM3eDz6vVzSZHvNKTXAU-95bY1c69dS4wxJs9ndI56IeZxNwoD7QfIt0mjFUg9njcEXdlLAyyWJwPtzQb3lxK-UCTon3GUPyU3joi2PGF3OMSyXaZI8hJ_rL51uKsx9wTutz8qQ3Q8IX53dDfnx4__36U7X7-vHz9btdZRvguVIKWtm3yjghse16sd2CcXwvOSipDIOukQJVI43lyhQNB2EbbBrFLROlsyGvT7lznH4umLIefTlkGMpy05I0B2hk122Lb0Pak9TGKaWIvZ6jH01cNTB95KQP-sxJHzlp1unCqfhenUcs-xHdg-sfmCJ4exJgOfTOY9TJli-x6HxEm7Wb_H9G_AUDz6hK</recordid><startdate>201811</startdate><enddate>201811</enddate><creator>Usui, Naotaka</creator><creator>Akamatsu, Naoki</creator><creator>Nakasato, Nobukazu</creator><creator>Ohnishi, Akihiro</creator><creator>Kaneko, Sunao</creator><creator>Hiramatsu, Hidetaka</creator><creator>Saeki, Kazunori</creator><creator>Miyagishi, Hideaki</creator><creator>Inoue, Yushi</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8164-4171</orcidid><orcidid>https://orcid.org/0000-0003-1331-7990</orcidid></search><sort><creationdate>201811</creationdate><title>Long-term tolerability, safety and efficacy of adjunctive perampanel in the open-label, dose-ascending Study 231 and extension Study 233 in Japanese patients with epilepsy</title><author>Usui, Naotaka ; Akamatsu, Naoki ; Nakasato, Nobukazu ; Ohnishi, Akihiro ; Kaneko, Sunao ; Hiramatsu, Hidetaka ; Saeki, Kazunori ; Miyagishi, Hideaki ; Inoue, Yushi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c412t-88156f58ad36e59f3771ad2b621868a019463e846ac28a36e213c4e4482c038a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>AMPA receptor</topic><topic>Anticonvulsants - adverse effects</topic><topic>Anticonvulsants - pharmacokinetics</topic><topic>Anticonvulsants - therapeutic use</topic><topic>Antiepileptic drugs</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Therapy, Combination</topic><topic>Drug Tolerance - physiology</topic><topic>Epilepsy</topic><topic>Epilepsy - drug therapy</topic><topic>Female</topic><topic>Humans</topic><topic>Japan</topic><topic>Longitudinal Studies</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Perampanel</topic><topic>Pyridones - adverse effects</topic><topic>Pyridones - pharmacokinetics</topic><topic>Pyridones - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Usui, Naotaka</creatorcontrib><creatorcontrib>Akamatsu, Naoki</creatorcontrib><creatorcontrib>Nakasato, Nobukazu</creatorcontrib><creatorcontrib>Ohnishi, Akihiro</creatorcontrib><creatorcontrib>Kaneko, Sunao</creatorcontrib><creatorcontrib>Hiramatsu, Hidetaka</creatorcontrib><creatorcontrib>Saeki, Kazunori</creatorcontrib><creatorcontrib>Miyagishi, Hideaki</creatorcontrib><creatorcontrib>Inoue, Yushi</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Seizure (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Usui, Naotaka</au><au>Akamatsu, Naoki</au><au>Nakasato, Nobukazu</au><au>Ohnishi, Akihiro</au><au>Kaneko, Sunao</au><au>Hiramatsu, Hidetaka</au><au>Saeki, Kazunori</au><au>Miyagishi, Hideaki</au><au>Inoue, Yushi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term tolerability, safety and efficacy of adjunctive perampanel in the open-label, dose-ascending Study 231 and extension Study 233 in Japanese patients with epilepsy</atitle><jtitle>Seizure (London, England)</jtitle><addtitle>Seizure</addtitle><date>2018-11</date><risdate>2018</risdate><volume>62</volume><spage>26</spage><epage>32</epage><pages>26-32</pages><issn>1059-1311</issn><eissn>1532-2688</eissn><abstract>•Studies 231/233 assessed perampanel tolerability in Japanese patients with POS.•33.3% of patients completing Study 231 achieved a maximum tolerated dose of 12 mg.•Median percent change in seizure frequency was –35.0% during Study 231.•In extension Study 233, 42.9% of patients received perampanel for ≤208 weeks.•Most treatment-related TEAEs were mild to moderate.
To evaluate long-term tolerability, safety and efficacy of adjunctive perampanel in a Phase II, multicentre, open-label, dose-ascending Study 231 (NCT00849212) and its extension (Study 233; NCT00903786) in Japanese patients with refractory partial-onset seizures (POS), with/without secondarily generalised seizures.
In Study 231, patients received adjunctive perampanel ≤12 mg/day during a 10-week treatment period. Patients completing Study 231 could enter Study 233 (≤316-week treatment period). Assessments included monitoring of treatment-related treatment-emergent adverse events (TEAEs), median percent change in seizure frequency per 28 days, 50% responder and seizure-freedom rates. During Study 231, a pharmacokinetic analysis assessed the effects of enzyme-inducing antiepileptic drugs.
Overall, 23/30 (76.7%) patients completed Study 231; 21/30 (70.0%) received perampanel ≥8 mg/day and 10/30 (33.3%) achieved a maximum tolerated dose of 12 mg/day. Median percent change in seizure frequency per 28 days was –35.0%. 50% responder rate was 37.0%; 4 (13.3%) patients achieved seizure freedom. Twenty-one patients entered Study 233. Mean duration of exposure was 195 weeks; 9 (42.9%) patients received perampanel for ≤208 weeks. Seizure control was sustained for 316 weeks in 3/21 (14.3%) patients; 2 achieved seizure freedom. Treatment-related TEAEs were tolerable; the most common was dizziness (Study 231, 53.3%; Study 233, 14.3%). Mean perampanel plasma concentrations were lower with concomitant carbamazepine vs non-inducers (152.7 ng/mL vs 389.4 ng/mL across perampanel groups); small patient numbers for non-inducers (n = 2) should be considered when interpreting these data.
Adjunctive perampanel demonstrated a favourable safety profile and long-term tolerability in Japanese patients with refractory POS for ≤316 weeks.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>30267941</pmid><doi>10.1016/j.seizure.2018.09.012</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-8164-4171</orcidid><orcidid>https://orcid.org/0000-0003-1331-7990</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adult AMPA receptor Anticonvulsants - adverse effects Anticonvulsants - pharmacokinetics Anticonvulsants - therapeutic use Antiepileptic drugs Dose-Response Relationship, Drug Drug Therapy, Combination Drug Tolerance - physiology Epilepsy Epilepsy - drug therapy Female Humans Japan Longitudinal Studies Male Middle Aged Perampanel Pyridones - adverse effects Pyridones - pharmacokinetics Pyridones - therapeutic use Treatment Outcome Young Adult |
| title | Long-term tolerability, safety and efficacy of adjunctive perampanel in the open-label, dose-ascending Study 231 and extension Study 233 in Japanese patients with epilepsy |
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