Safety and tolerability of adjunctive brivaracetam in children with focal seizures: Interim analysis of pooled data from two open-label trials
To evaluate long-term safety and tolerability of adjunctive brivaracetam (BRV) in children with epilepsy. This was an interim analysis (cut-off March 15, 2017) of pooled data from two open-label, single-arm, multicentre trials. N01263 (NCT00422422) was a 3-week trial of BRV 0.8–4 mg/kg/day in patien...
Gespeichert in:
| Veröffentlicht in: | European journal of paediatric neurology 2020-03, Vol.25, p.68-76 |
|---|---|
| Hauptverfasser: | , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 76 |
|---|---|
| container_issue | |
| container_start_page | 68 |
| container_title | European journal of paediatric neurology |
| container_volume | 25 |
| creator | Patel, Anup D. Badalamenti, Vincent Gasalla, Teresa Elmoufti, Sami Elshoff, Jan-Peer |
| description | To evaluate long-term safety and tolerability of adjunctive brivaracetam (BRV) in children with epilepsy.
This was an interim analysis (cut-off March 15, 2017) of pooled data from two open-label, single-arm, multicentre trials. N01263 (NCT00422422) was a 3-week trial of BRV 0.8–4 mg/kg/day in patients (1 month– |
| doi_str_mv | 10.1016/j.ejpn.2019.11.007 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2322754957</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1090379819304167</els_id><sourcerecordid>2322754957</sourcerecordid><originalsourceid>FETCH-LOGICAL-c400t-1a386ceff993ff7089daa7e22103fc872a487cac5d7a4894b09e066230993d683</originalsourceid><addsrcrecordid>eNp9kc1u1TAQhSMEoqXwAiyQl2wSbOfHMWKDKn4qVWIBrK2JPVYdOXGwnVtdHqLPjK9uYclqjkbnfNLMqarXjDaMsuHd3OC8rQ2nTDaMNZSKJ9Ul61tec9bSp0VTSetWyPGiepHSTCmVHR-eVxctGxnthbisHr6DxXwksBqSg8cIk_OuLIIlYOZ91dkdkEzRHSCCxgwLcSvRd86biCu5d_mO2KDBk4Tu9x4xvSc3a8bolgIFf0wunWBbKHRDDGQgNoaF5PtAwoZr7WFCT3J04NPL6pktA189zqvq5-dPP66_1rffvtxcf7ytdUdprhm046DRWilbawUdpQEQyDmjrdWj4NCNQoPujShKdhOVSIeBt7QEzDC2V9XbM3eL4deOKavFJY3ew4phT4q3nIu-k70oVn626hhSimjVVm6DeFSMqlMPalanHtSpB8WYKj2U0JtH_j4taP5F_j6-GD6cDViuPDiMKmmHq0bjIuqsTHD_4_8BcqWb8Q</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2322754957</pqid></control><display><type>article</type><title>Safety and tolerability of adjunctive brivaracetam in children with focal seizures: Interim analysis of pooled data from two open-label trials</title><source>Elsevier ScienceDirect Journals Complete</source><creator>Patel, Anup D. ; Badalamenti, Vincent ; Gasalla, Teresa ; Elmoufti, Sami ; Elshoff, Jan-Peer</creator><creatorcontrib>Patel, Anup D. ; Badalamenti, Vincent ; Gasalla, Teresa ; Elmoufti, Sami ; Elshoff, Jan-Peer</creatorcontrib><description>To evaluate long-term safety and tolerability of adjunctive brivaracetam (BRV) in children with epilepsy.
This was an interim analysis (cut-off March 15, 2017) of pooled data from two open-label, single-arm, multicentre trials. N01263 (NCT00422422) was a 3-week trial of BRV 0.8–4 mg/kg/day in patients (1 month–<16 years) with epilepsy. Patients who completed this trial could continue into a long-term follow-up trial (N01266, NCT01364597) which also directly enrolled patients (4–<17 years) with focal seizures. After dose-escalation, patients received BRV 1–5 mg/kg/day (maximum 200 mg/day) during long-term evaluation. Data are reported for patients aged 4 to <16 years with focal seizures.
The safety set comprised 149 patients: 34 from the initial trial (26 entered long-term trial) and 115 directly enrolled into the long-term trial. At the cut-off, 90 patients were receiving BRV (total exposure: 299.4 patient-years). Treatment-emergent adverse events (TEAEs) were reported by 140/149 (94.0%) patients, most commonly (≥20%) nasopharyngitis (24.8%), pharyngitis (22.1%), convulsion (21.5%), and pyrexia (20.1%). TEAEs considered drug-related by the investigator were reported by 56/149 (37.6%) patients, most commonly somnolence (6.0%). Two patients died; neither death was considered related to BRV. Mean changes from baseline in child behaviour rating scales were small; most patients remained in their baseline category.
In this pooled analysis of two open-label trials including long-term data, adjunctive BRV was generally well tolerated in children aged 4 to <16 years with focal seizures. These findings supported approval of BRV as a new therapy option for children aged ≥4 years with focal seizures.
•Tolerability of adjunctive BRV in 149 children (4 to <16 years) with focal seizures.•Total BRV exposure was 299.4 patient-years, with 2 patients treated for 5.5 years.•TEAE were considered drug-related in 37.6% of patients (most common: somnolence 6.0%).•Changes in child behaviour rating scales were small, indicating stability over time.•Data support BRV as a treatment option for patients (≥4 years) with focal seizures.</description><identifier>ISSN: 1090-3798</identifier><identifier>EISSN: 1532-2130</identifier><identifier>DOI: 10.1016/j.ejpn.2019.11.007</identifier><identifier>PMID: 31810577</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Antiepileptic drug ; Epilepsy syndrome ; Focal seizure ; Paediatric</subject><ispartof>European journal of paediatric neurology, 2020-03, Vol.25, p.68-76</ispartof><rights>2019 The Authors</rights><rights>Copyright © 2019 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-c400t-1a386ceff993ff7089daa7e22103fc872a487cac5d7a4894b09e066230993d683</citedby><cites>FETCH-LOGICAL-c400t-1a386ceff993ff7089daa7e22103fc872a487cac5d7a4894b09e066230993d683</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejpn.2019.11.007$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,45974</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31810577$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Patel, Anup D.</creatorcontrib><creatorcontrib>Badalamenti, Vincent</creatorcontrib><creatorcontrib>Gasalla, Teresa</creatorcontrib><creatorcontrib>Elmoufti, Sami</creatorcontrib><creatorcontrib>Elshoff, Jan-Peer</creatorcontrib><title>Safety and tolerability of adjunctive brivaracetam in children with focal seizures: Interim analysis of pooled data from two open-label trials</title><title>European journal of paediatric neurology</title><addtitle>Eur J Paediatr Neurol</addtitle><description>To evaluate long-term safety and tolerability of adjunctive brivaracetam (BRV) in children with epilepsy.
This was an interim analysis (cut-off March 15, 2017) of pooled data from two open-label, single-arm, multicentre trials. N01263 (NCT00422422) was a 3-week trial of BRV 0.8–4 mg/kg/day in patients (1 month–<16 years) with epilepsy. Patients who completed this trial could continue into a long-term follow-up trial (N01266, NCT01364597) which also directly enrolled patients (4–<17 years) with focal seizures. After dose-escalation, patients received BRV 1–5 mg/kg/day (maximum 200 mg/day) during long-term evaluation. Data are reported for patients aged 4 to <16 years with focal seizures.
The safety set comprised 149 patients: 34 from the initial trial (26 entered long-term trial) and 115 directly enrolled into the long-term trial. At the cut-off, 90 patients were receiving BRV (total exposure: 299.4 patient-years). Treatment-emergent adverse events (TEAEs) were reported by 140/149 (94.0%) patients, most commonly (≥20%) nasopharyngitis (24.8%), pharyngitis (22.1%), convulsion (21.5%), and pyrexia (20.1%). TEAEs considered drug-related by the investigator were reported by 56/149 (37.6%) patients, most commonly somnolence (6.0%). Two patients died; neither death was considered related to BRV. Mean changes from baseline in child behaviour rating scales were small; most patients remained in their baseline category.
In this pooled analysis of two open-label trials including long-term data, adjunctive BRV was generally well tolerated in children aged 4 to <16 years with focal seizures. These findings supported approval of BRV as a new therapy option for children aged ≥4 years with focal seizures.
•Tolerability of adjunctive BRV in 149 children (4 to <16 years) with focal seizures.•Total BRV exposure was 299.4 patient-years, with 2 patients treated for 5.5 years.•TEAE were considered drug-related in 37.6% of patients (most common: somnolence 6.0%).•Changes in child behaviour rating scales were small, indicating stability over time.•Data support BRV as a treatment option for patients (≥4 years) with focal seizures.</description><subject>Antiepileptic drug</subject><subject>Epilepsy syndrome</subject><subject>Focal seizure</subject><subject>Paediatric</subject><issn>1090-3798</issn><issn>1532-2130</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kc1u1TAQhSMEoqXwAiyQl2wSbOfHMWKDKn4qVWIBrK2JPVYdOXGwnVtdHqLPjK9uYclqjkbnfNLMqarXjDaMsuHd3OC8rQ2nTDaMNZSKJ9Ul61tec9bSp0VTSetWyPGiepHSTCmVHR-eVxctGxnthbisHr6DxXwksBqSg8cIk_OuLIIlYOZ91dkdkEzRHSCCxgwLcSvRd86biCu5d_mO2KDBk4Tu9x4xvSc3a8bolgIFf0wunWBbKHRDDGQgNoaF5PtAwoZr7WFCT3J04NPL6pktA189zqvq5-dPP66_1rffvtxcf7ytdUdprhm046DRWilbawUdpQEQyDmjrdWj4NCNQoPujShKdhOVSIeBt7QEzDC2V9XbM3eL4deOKavFJY3ew4phT4q3nIu-k70oVn626hhSimjVVm6DeFSMqlMPalanHtSpB8WYKj2U0JtH_j4taP5F_j6-GD6cDViuPDiMKmmHq0bjIuqsTHD_4_8BcqWb8Q</recordid><startdate>202003</startdate><enddate>202003</enddate><creator>Patel, Anup D.</creator><creator>Badalamenti, Vincent</creator><creator>Gasalla, Teresa</creator><creator>Elmoufti, Sami</creator><creator>Elshoff, Jan-Peer</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202003</creationdate><title>Safety and tolerability of adjunctive brivaracetam in children with focal seizures: Interim analysis of pooled data from two open-label trials</title><author>Patel, Anup D. ; Badalamenti, Vincent ; Gasalla, Teresa ; Elmoufti, Sami ; Elshoff, Jan-Peer</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c400t-1a386ceff993ff7089daa7e22103fc872a487cac5d7a4894b09e066230993d683</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antiepileptic drug</topic><topic>Epilepsy syndrome</topic><topic>Focal seizure</topic><topic>Paediatric</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Patel, Anup D.</creatorcontrib><creatorcontrib>Badalamenti, Vincent</creatorcontrib><creatorcontrib>Gasalla, Teresa</creatorcontrib><creatorcontrib>Elmoufti, Sami</creatorcontrib><creatorcontrib>Elshoff, Jan-Peer</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of paediatric neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Patel, Anup D.</au><au>Badalamenti, Vincent</au><au>Gasalla, Teresa</au><au>Elmoufti, Sami</au><au>Elshoff, Jan-Peer</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and tolerability of adjunctive brivaracetam in children with focal seizures: Interim analysis of pooled data from two open-label trials</atitle><jtitle>European journal of paediatric neurology</jtitle><addtitle>Eur J Paediatr Neurol</addtitle><date>2020-03</date><risdate>2020</risdate><volume>25</volume><spage>68</spage><epage>76</epage><pages>68-76</pages><issn>1090-3798</issn><eissn>1532-2130</eissn><abstract>To evaluate long-term safety and tolerability of adjunctive brivaracetam (BRV) in children with epilepsy.
This was an interim analysis (cut-off March 15, 2017) of pooled data from two open-label, single-arm, multicentre trials. N01263 (NCT00422422) was a 3-week trial of BRV 0.8–4 mg/kg/day in patients (1 month–<16 years) with epilepsy. Patients who completed this trial could continue into a long-term follow-up trial (N01266, NCT01364597) which also directly enrolled patients (4–<17 years) with focal seizures. After dose-escalation, patients received BRV 1–5 mg/kg/day (maximum 200 mg/day) during long-term evaluation. Data are reported for patients aged 4 to <16 years with focal seizures.
The safety set comprised 149 patients: 34 from the initial trial (26 entered long-term trial) and 115 directly enrolled into the long-term trial. At the cut-off, 90 patients were receiving BRV (total exposure: 299.4 patient-years). Treatment-emergent adverse events (TEAEs) were reported by 140/149 (94.0%) patients, most commonly (≥20%) nasopharyngitis (24.8%), pharyngitis (22.1%), convulsion (21.5%), and pyrexia (20.1%). TEAEs considered drug-related by the investigator were reported by 56/149 (37.6%) patients, most commonly somnolence (6.0%). Two patients died; neither death was considered related to BRV. Mean changes from baseline in child behaviour rating scales were small; most patients remained in their baseline category.
In this pooled analysis of two open-label trials including long-term data, adjunctive BRV was generally well tolerated in children aged 4 to <16 years with focal seizures. These findings supported approval of BRV as a new therapy option for children aged ≥4 years with focal seizures.
•Tolerability of adjunctive BRV in 149 children (4 to <16 years) with focal seizures.•Total BRV exposure was 299.4 patient-years, with 2 patients treated for 5.5 years.•TEAE were considered drug-related in 37.6% of patients (most common: somnolence 6.0%).•Changes in child behaviour rating scales were small, indicating stability over time.•Data support BRV as a treatment option for patients (≥4 years) with focal seizures.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>31810577</pmid><doi>10.1016/j.ejpn.2019.11.007</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1090-3798 |
| ispartof | European journal of paediatric neurology, 2020-03, Vol.25, p.68-76 |
| issn | 1090-3798 1532-2130 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2322754957 |
| source | Elsevier ScienceDirect Journals Complete |
| subjects | Antiepileptic drug Epilepsy syndrome Focal seizure Paediatric |
| title | Safety and tolerability of adjunctive brivaracetam in children with focal seizures: Interim analysis of pooled data from two open-label trials |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-22T18%3A43%3A43IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Safety%20and%20tolerability%20of%20adjunctive%20brivaracetam%20in%20children%20with%20focal%20seizures:%20Interim%20analysis%20of%20pooled%20data%20from%20two%20open-label%20trials&rft.jtitle=European%20journal%20of%20paediatric%20neurology&rft.au=Patel,%20Anup%20D.&rft.date=2020-03&rft.volume=25&rft.spage=68&rft.epage=76&rft.pages=68-76&rft.issn=1090-3798&rft.eissn=1532-2130&rft_id=info:doi/10.1016/j.ejpn.2019.11.007&rft_dat=%3Cproquest_cross%3E2322754957%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2322754957&rft_id=info:pmid/31810577&rft_els_id=S1090379819304167&rfr_iscdi=true |