Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome
Among children and young adults with the Dravet syndrome, a developmental disorder that is associated with treatment-resistant seizures, cannabidiol reduced the frequency of convulsive seizures but caused sleepiness and elevated liver enzymes in some patients. Seizures are difficult to control in th...
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| Veröffentlicht in: | The New England journal of medicine 2017-05, Vol.376 (21), p.2011-2020 |
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| container_end_page | 2020 |
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| container_issue | 21 |
| container_start_page | 2011 |
| container_title | The New England journal of medicine |
| container_volume | 376 |
| creator | Devinsky, Orrin Cross, J. Helen Laux, Linda Marsh, Eric Miller, Ian Nabbout, Rima Scheffer, Ingrid E Thiele, Elizabeth A Wright, Stephen |
| description | Among children and young adults with the Dravet syndrome, a developmental disorder that is associated with treatment-resistant seizures, cannabidiol reduced the frequency of convulsive seizures but caused sleepiness and elevated liver enzymes in some patients.
Seizures are difficult to control in the Dravet syndrome, a rare genetic form of epileptic encephalopathy primarily due to loss-of-function mutations in the
SCN1A
gene. Interest in cannabidiol for the treatment of epilepsy was generated by media reports of efficacy in children with the Dravet syndrome.
1
Four small trials of cannabidiol had yielded mixed results.
2
–
5
A series of in vitro and in vivo preclinical models of seizure showed that cannabidiol had activity against convulsive seizures.
6
Subsequently, the safety and effectiveness of a standardized oral solution of cannabidiol was tested in an open-label trial involving 214 children and young adults . . . |
| doi_str_mv | 10.1056/NEJMoa1611618 |
| format | Article |
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Seizures are difficult to control in the Dravet syndrome, a rare genetic form of epileptic encephalopathy primarily due to loss-of-function mutations in the
SCN1A
gene. Interest in cannabidiol for the treatment of epilepsy was generated by media reports of efficacy in children with the Dravet syndrome.
1
Four small trials of cannabidiol had yielded mixed results.
2
–
5
A series of in vitro and in vivo preclinical models of seizure showed that cannabidiol had activity against convulsive seizures.
6
Subsequently, the safety and effectiveness of a standardized oral solution of cannabidiol was tested in an open-label trial involving 214 children and young adults . . .</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMoa1611618</identifier><identifier>PMID: 28538134</identifier><language>eng</language><publisher>United States: Massachusetts Medical Society</publisher><subject>Adolescent ; Anticonvulsants - adverse effects ; Anticonvulsants - therapeutic use ; Cannabidiol - adverse effects ; Cannabidiol - therapeutic use ; Child ; Child, Preschool ; Children & youth ; Clinical trials ; Convulsions & seizures ; Double-Blind Method ; Drug resistance ; Drug therapy ; Epilepsies, Myoclonic - drug therapy ; Epilepsy ; Fatigue - chemically induced ; Female ; Humans ; Liver - drug effects ; Liver Function Tests ; Male ; Medical marijuana ; Seizures ; Seizures - prevention & control</subject><ispartof>The New England journal of medicine, 2017-05, Vol.376 (21), p.2011-2020</ispartof><rights>Copyright © 2017 Massachusetts Medical Society. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c500t-4851cca3eaf8fbf7a0f4c20cf80649a7c24501a193335a3f0ae8b093f11fa40f3</citedby><cites>FETCH-LOGICAL-c500t-4851cca3eaf8fbf7a0f4c20cf80649a7c24501a193335a3f0ae8b093f11fa40f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJMoa1611618$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJMoa1611618$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>314,776,780,2746,2747,26080,27901,27902,52357,54039</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28538134$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Devinsky, Orrin</creatorcontrib><creatorcontrib>Cross, J. Helen</creatorcontrib><creatorcontrib>Laux, Linda</creatorcontrib><creatorcontrib>Marsh, Eric</creatorcontrib><creatorcontrib>Miller, Ian</creatorcontrib><creatorcontrib>Nabbout, Rima</creatorcontrib><creatorcontrib>Scheffer, Ingrid E</creatorcontrib><creatorcontrib>Thiele, Elizabeth A</creatorcontrib><creatorcontrib>Wright, Stephen</creatorcontrib><creatorcontrib>Cannabidiol in Dravet Syndrome Study Group</creatorcontrib><title>Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>Among children and young adults with the Dravet syndrome, a developmental disorder that is associated with treatment-resistant seizures, cannabidiol reduced the frequency of convulsive seizures but caused sleepiness and elevated liver enzymes in some patients.
Seizures are difficult to control in the Dravet syndrome, a rare genetic form of epileptic encephalopathy primarily due to loss-of-function mutations in the
SCN1A
gene. Interest in cannabidiol for the treatment of epilepsy was generated by media reports of efficacy in children with the Dravet syndrome.
1
Four small trials of cannabidiol had yielded mixed results.
2
–
5
A series of in vitro and in vivo preclinical models of seizure showed that cannabidiol had activity against convulsive seizures.
6
Subsequently, the safety and effectiveness of a standardized oral solution of cannabidiol was tested in an open-label trial involving 214 children and young adults . . .</description><subject>Adolescent</subject><subject>Anticonvulsants - adverse effects</subject><subject>Anticonvulsants - therapeutic use</subject><subject>Cannabidiol - adverse effects</subject><subject>Cannabidiol - therapeutic use</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children & youth</subject><subject>Clinical trials</subject><subject>Convulsions & seizures</subject><subject>Double-Blind Method</subject><subject>Drug resistance</subject><subject>Drug therapy</subject><subject>Epilepsies, Myoclonic - drug therapy</subject><subject>Epilepsy</subject><subject>Fatigue - chemically induced</subject><subject>Female</subject><subject>Humans</subject><subject>Liver - drug effects</subject><subject>Liver Function Tests</subject><subject>Male</subject><subject>Medical marijuana</subject><subject>Seizures</subject><subject>Seizures - prevention & control</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp10F1LwzAUBuAgipvTS2-lIII31ZMm7dJLmXMqfoDO63KaJdrRJjNphfnrjW4KCoZAIHl4OXkJ2adwQiHNTu_G17cWaUbDFhukT1PGYs4h2yR9gETEfJizHtnxfg5hUZ5vk14iUiYo430ymboK68jqaITGYFnNKltH2rro3HXP8YPylW_RtNGjqt47p3xUmah9UeEZ31S4XpqZs43aJVsaa6_21ueAPF2Mp6PL-OZ-cjU6u4llCtDGXKRUSmQKtdClHiJoLhOQWkDGcxzKhKdAkeaMsRSZBlSihJxpSjVy0GxAjle5C2dfO-Xboqm8VHWNRtnOFzSHhAs2DB8ckMM_dG47Z8J0X4pmnIo8qHilpLPeO6WLhasadMuCQvHZcPGr4eAP1qld2ajZj_6uNICjFWgaXxg1b_4J-gA-yIBG</recordid><startdate>20170525</startdate><enddate>20170525</enddate><creator>Devinsky, Orrin</creator><creator>Cross, J. 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Helen ; Laux, Linda ; Marsh, Eric ; Miller, Ian ; Nabbout, Rima ; Scheffer, Ingrid E ; Thiele, Elizabeth A ; Wright, Stephen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c500t-4851cca3eaf8fbf7a0f4c20cf80649a7c24501a193335a3f0ae8b093f11fa40f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Anticonvulsants - adverse effects</topic><topic>Anticonvulsants - therapeutic use</topic><topic>Cannabidiol - adverse effects</topic><topic>Cannabidiol - therapeutic use</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children & youth</topic><topic>Clinical trials</topic><topic>Convulsions & seizures</topic><topic>Double-Blind Method</topic><topic>Drug resistance</topic><topic>Drug therapy</topic><topic>Epilepsies, Myoclonic - drug therapy</topic><topic>Epilepsy</topic><topic>Fatigue - chemically induced</topic><topic>Female</topic><topic>Humans</topic><topic>Liver - drug effects</topic><topic>Liver Function Tests</topic><topic>Male</topic><topic>Medical marijuana</topic><topic>Seizures</topic><topic>Seizures - prevention & control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Devinsky, Orrin</creatorcontrib><creatorcontrib>Cross, J. Helen</creatorcontrib><creatorcontrib>Laux, Linda</creatorcontrib><creatorcontrib>Marsh, Eric</creatorcontrib><creatorcontrib>Miller, Ian</creatorcontrib><creatorcontrib>Nabbout, Rima</creatorcontrib><creatorcontrib>Scheffer, Ingrid E</creatorcontrib><creatorcontrib>Thiele, Elizabeth A</creatorcontrib><creatorcontrib>Wright, Stephen</creatorcontrib><creatorcontrib>Cannabidiol in Dravet Syndrome Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>New England Journal of Medicine</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The New England journal of medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Devinsky, Orrin</au><au>Cross, J. Helen</au><au>Laux, Linda</au><au>Marsh, Eric</au><au>Miller, Ian</au><au>Nabbout, Rima</au><au>Scheffer, Ingrid E</au><au>Thiele, Elizabeth A</au><au>Wright, Stephen</au><aucorp>Cannabidiol in Dravet Syndrome Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome</atitle><jtitle>The New England journal of medicine</jtitle><addtitle>N Engl J Med</addtitle><date>2017-05-25</date><risdate>2017</risdate><volume>376</volume><issue>21</issue><spage>2011</spage><epage>2020</epage><pages>2011-2020</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><abstract>Among children and young adults with the Dravet syndrome, a developmental disorder that is associated with treatment-resistant seizures, cannabidiol reduced the frequency of convulsive seizures but caused sleepiness and elevated liver enzymes in some patients.
Seizures are difficult to control in the Dravet syndrome, a rare genetic form of epileptic encephalopathy primarily due to loss-of-function mutations in the
SCN1A
gene. Interest in cannabidiol for the treatment of epilepsy was generated by media reports of efficacy in children with the Dravet syndrome.
1
Four small trials of cannabidiol had yielded mixed results.
2
–
5
A series of in vitro and in vivo preclinical models of seizure showed that cannabidiol had activity against convulsive seizures.
6
Subsequently, the safety and effectiveness of a standardized oral solution of cannabidiol was tested in an open-label trial involving 214 children and young adults . . .</abstract><cop>United States</cop><pub>Massachusetts Medical Society</pub><pmid>28538134</pmid><doi>10.1056/NEJMoa1611618</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0028-4793 |
| ispartof | The New England journal of medicine, 2017-05, Vol.376 (21), p.2011-2020 |
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| language | eng |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; New England Journal of Medicine |
| subjects | Adolescent Anticonvulsants - adverse effects Anticonvulsants - therapeutic use Cannabidiol - adverse effects Cannabidiol - therapeutic use Child Child, Preschool Children & youth Clinical trials Convulsions & seizures Double-Blind Method Drug resistance Drug therapy Epilepsies, Myoclonic - drug therapy Epilepsy Fatigue - chemically induced Female Humans Liver - drug effects Liver Function Tests Male Medical marijuana Seizures Seizures - prevention & control |
| title | Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome |
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