HAGIL (Hamburg Vigil Study): a randomized placebo-controlled double-blind study with modafinil for treatment of fatigue in patients with multiple sclerosis
Objective: To reassess the effect of modafinil, a wakefulness-promoting artificial psychostimulant, on fatigue and neuropsychological measures in patients with multiple sclerosis. Methods: Multiple sclerosis (MS) patients with a baseline score of ≥4 on the Fatigue Severity Scale (FSS) and an Expande...
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| Veröffentlicht in: | Multiple sclerosis 2011-08, Vol.17 (8), p.1002-1009 |
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| creator | Möller, F Poettgen, J Broemel, F Neuhaus, A Daumer, M Heesen, C |
| description | Objective: To reassess the effect of modafinil, a wakefulness-promoting artificial psychostimulant, on fatigue and neuropsychological measures in patients with multiple sclerosis.
Methods: Multiple sclerosis (MS) patients with a baseline score of ≥4 on the Fatigue Severity Scale (FSS) and an Expanded Disability Status Scale score |
| doi_str_mv | 10.1177/1352458511402410 |
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| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_878030528</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_1352458511402410</sage_id><sourcerecordid>2439368261</sourcerecordid><originalsourceid>FETCH-LOGICAL-c393t-317829a3b58547a338a45f9fd661b92a629878be956dea26edb3183ab7c080c53</originalsourceid><addsrcrecordid>eNp1kU2LFDEQhoMo7rp69yRBEPXQmnQ6ncTbsujOwoAHP65N5aPHLOlOm6SR9a_4Z804owsLnlJUPW_lLV6EnlLyhlIh3lLG245LTmlH2o6Se-iUdkI0RAlyv9Z13OznJ-hRzteEECEYf4hOWsp7qrg6Rb8255dXW_xqA5Ne0w5_9Tsf8Key2pvX7zDgBLONk__pLF4CGKdjY-JcUgyhtmxcdXCNDn62OO9F-Icv3_AULYx-rpvGmHBJDsrk5oLjiEcofrc67Ge81LJ281GzhuKX4HA2waWYfX6MHowQsntyfM_Qlw_vP19smu3Hy6uL821jmGKlYVTIVgHT9dBOAGMSOj6q0fY91aqFvlVSSO0U762DtndWMyoZaGGIJIazM_TysHdJ8fvqchkmn40LAWYX1zxUNWGEt7KSz--Q13FNczU3SNkzLhTpKkQOkKlX5OTGYUl-gnQzUDLsYxvuxlYlz457Vz05-0_wN6cKvDgCkA2EscZifL7lOsaU_GOwOXAZdu7W3H8__g3P3K0e</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>886357904</pqid></control><display><type>article</type><title>HAGIL (Hamburg Vigil Study): a randomized placebo-controlled double-blind study with modafinil for treatment of fatigue in patients with multiple sclerosis</title><source>MEDLINE</source><source>SAGE Complete</source><creator>Möller, F ; Poettgen, J ; Broemel, F ; Neuhaus, A ; Daumer, M ; Heesen, C</creator><creatorcontrib>Möller, F ; Poettgen, J ; Broemel, F ; Neuhaus, A ; Daumer, M ; Heesen, C</creatorcontrib><description>Objective: To reassess the effect of modafinil, a wakefulness-promoting artificial psychostimulant, on fatigue and neuropsychological measures in patients with multiple sclerosis.
Methods: Multiple sclerosis (MS) patients with a baseline score of ≥4 on the Fatigue Severity Scale (FSS) and an Expanded Disability Status Scale score <7 were eligible for the 8-week randomized, double-blind, placebo-controlled study. Modafinil was dosed up to 200 mg/day within 1 week. Assessments were performed at baseline and after 4 and 8 weeks. The primary outcome parameter was the mean change of the FSS mean score. Secondary outcome variables were other questionnaires covering fatigue, daytime sleepiness and sleep quality. Cognitive impairment was assessed by the oral version of the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT).
Results: The study included 121 MS patients. Dropout rate was 9%. Both treatment groups showed improvements through time. While mean FSS at 8 weeks showed a trend difference between groups in the intention-to-treat analysis, the primary endpoint was not met. Assessment of cognitive impairment by SDMT and PASAT showed contradictory results. All other secondary endpoints were not met. There was no major safety concern.
Conclusions: In general, the study does not support modafinil as an effective treatment for MS fatigue. However, the study shows the need for new study designs and endpoints in MS fatigue studies.</description><identifier>ISSN: 1352-4585</identifier><identifier>EISSN: 1477-0970</identifier><identifier>DOI: 10.1177/1352458511402410</identifier><identifier>PMID: 21561959</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Adult ; Benzhydryl Compounds - therapeutic use ; Biological and medical sciences ; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases ; Double-Blind Method ; Fatigue - drug therapy ; Fatigue - etiology ; Female ; Humans ; Male ; Medical sciences ; Multiple Sclerosis - complications ; Multiple Sclerosis - drug therapy ; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis ; Neurology ; Neuroprotective Agents - therapeutic use</subject><ispartof>Multiple sclerosis, 2011-08, Vol.17 (8), p.1002-1009</ispartof><rights>The Author(s) 2011</rights><rights>2015 INIST-CNRS</rights><rights>SAGE Publications © Aug 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-317829a3b58547a338a45f9fd661b92a629878be956dea26edb3183ab7c080c53</citedby><cites>FETCH-LOGICAL-c393t-317829a3b58547a338a45f9fd661b92a629878be956dea26edb3183ab7c080c53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1352458511402410$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1352458511402410$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21798,27901,27902,43597,43598</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24339828$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21561959$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Möller, F</creatorcontrib><creatorcontrib>Poettgen, J</creatorcontrib><creatorcontrib>Broemel, F</creatorcontrib><creatorcontrib>Neuhaus, A</creatorcontrib><creatorcontrib>Daumer, M</creatorcontrib><creatorcontrib>Heesen, C</creatorcontrib><title>HAGIL (Hamburg Vigil Study): a randomized placebo-controlled double-blind study with modafinil for treatment of fatigue in patients with multiple sclerosis</title><title>Multiple sclerosis</title><addtitle>Mult Scler</addtitle><description>Objective: To reassess the effect of modafinil, a wakefulness-promoting artificial psychostimulant, on fatigue and neuropsychological measures in patients with multiple sclerosis.
Methods: Multiple sclerosis (MS) patients with a baseline score of ≥4 on the Fatigue Severity Scale (FSS) and an Expanded Disability Status Scale score <7 were eligible for the 8-week randomized, double-blind, placebo-controlled study. Modafinil was dosed up to 200 mg/day within 1 week. Assessments were performed at baseline and after 4 and 8 weeks. The primary outcome parameter was the mean change of the FSS mean score. Secondary outcome variables were other questionnaires covering fatigue, daytime sleepiness and sleep quality. Cognitive impairment was assessed by the oral version of the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT).
Results: The study included 121 MS patients. Dropout rate was 9%. Both treatment groups showed improvements through time. While mean FSS at 8 weeks showed a trend difference between groups in the intention-to-treat analysis, the primary endpoint was not met. Assessment of cognitive impairment by SDMT and PASAT showed contradictory results. All other secondary endpoints were not met. There was no major safety concern.
Conclusions: In general, the study does not support modafinil as an effective treatment for MS fatigue. However, the study shows the need for new study designs and endpoints in MS fatigue studies.</description><subject>Adult</subject><subject>Benzhydryl Compounds - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases</subject><subject>Double-Blind Method</subject><subject>Fatigue - drug therapy</subject><subject>Fatigue - etiology</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Multiple Sclerosis - complications</subject><subject>Multiple Sclerosis - drug therapy</subject><subject>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</subject><subject>Neurology</subject><subject>Neuroprotective Agents - therapeutic use</subject><issn>1352-4585</issn><issn>1477-0970</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kU2LFDEQhoMo7rp69yRBEPXQmnQ6ncTbsujOwoAHP65N5aPHLOlOm6SR9a_4Z804owsLnlJUPW_lLV6EnlLyhlIh3lLG245LTmlH2o6Se-iUdkI0RAlyv9Z13OznJ-hRzteEECEYf4hOWsp7qrg6Rb8255dXW_xqA5Ne0w5_9Tsf8Key2pvX7zDgBLONk__pLF4CGKdjY-JcUgyhtmxcdXCNDn62OO9F-Icv3_AULYx-rpvGmHBJDsrk5oLjiEcofrc67Ge81LJ281GzhuKX4HA2waWYfX6MHowQsntyfM_Qlw_vP19smu3Hy6uL821jmGKlYVTIVgHT9dBOAGMSOj6q0fY91aqFvlVSSO0U762DtndWMyoZaGGIJIazM_TysHdJ8fvqchkmn40LAWYX1zxUNWGEt7KSz--Q13FNczU3SNkzLhTpKkQOkKlX5OTGYUl-gnQzUDLsYxvuxlYlz457Vz05-0_wN6cKvDgCkA2EscZifL7lOsaU_GOwOXAZdu7W3H8__g3P3K0e</recordid><startdate>20110801</startdate><enddate>20110801</enddate><creator>Möller, F</creator><creator>Poettgen, J</creator><creator>Broemel, F</creator><creator>Neuhaus, A</creator><creator>Daumer, M</creator><creator>Heesen, C</creator><general>SAGE Publications</general><general>Sage Publications</general><general>Sage Publications Ltd</general><scope>IQODW</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>3V.</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20110801</creationdate><title>HAGIL (Hamburg Vigil Study): a randomized placebo-controlled double-blind study with modafinil for treatment of fatigue in patients with multiple sclerosis</title><author>Möller, F ; Poettgen, J ; Broemel, F ; Neuhaus, A ; Daumer, M ; Heesen, C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-317829a3b58547a338a45f9fd661b92a629878be956dea26edb3183ab7c080c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Benzhydryl Compounds - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases</topic><topic>Double-Blind Method</topic><topic>Fatigue - drug therapy</topic><topic>Fatigue - etiology</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Multiple Sclerosis - complications</topic><topic>Multiple Sclerosis - drug therapy</topic><topic>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</topic><topic>Neurology</topic><topic>Neuroprotective Agents - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Möller, F</creatorcontrib><creatorcontrib>Poettgen, J</creatorcontrib><creatorcontrib>Broemel, F</creatorcontrib><creatorcontrib>Neuhaus, A</creatorcontrib><creatorcontrib>Daumer, M</creatorcontrib><creatorcontrib>Heesen, C</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</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>MEDLINE - Academic</collection><jtitle>Multiple sclerosis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Möller, F</au><au>Poettgen, J</au><au>Broemel, F</au><au>Neuhaus, A</au><au>Daumer, M</au><au>Heesen, C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>HAGIL (Hamburg Vigil Study): a randomized placebo-controlled double-blind study with modafinil for treatment of fatigue in patients with multiple sclerosis</atitle><jtitle>Multiple sclerosis</jtitle><addtitle>Mult Scler</addtitle><date>2011-08-01</date><risdate>2011</risdate><volume>17</volume><issue>8</issue><spage>1002</spage><epage>1009</epage><pages>1002-1009</pages><issn>1352-4585</issn><eissn>1477-0970</eissn><abstract>Objective: To reassess the effect of modafinil, a wakefulness-promoting artificial psychostimulant, on fatigue and neuropsychological measures in patients with multiple sclerosis.
Methods: Multiple sclerosis (MS) patients with a baseline score of ≥4 on the Fatigue Severity Scale (FSS) and an Expanded Disability Status Scale score <7 were eligible for the 8-week randomized, double-blind, placebo-controlled study. Modafinil was dosed up to 200 mg/day within 1 week. Assessments were performed at baseline and after 4 and 8 weeks. The primary outcome parameter was the mean change of the FSS mean score. Secondary outcome variables were other questionnaires covering fatigue, daytime sleepiness and sleep quality. Cognitive impairment was assessed by the oral version of the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT).
Results: The study included 121 MS patients. Dropout rate was 9%. Both treatment groups showed improvements through time. While mean FSS at 8 weeks showed a trend difference between groups in the intention-to-treat analysis, the primary endpoint was not met. Assessment of cognitive impairment by SDMT and PASAT showed contradictory results. All other secondary endpoints were not met. There was no major safety concern.
Conclusions: In general, the study does not support modafinil as an effective treatment for MS fatigue. However, the study shows the need for new study designs and endpoints in MS fatigue studies.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>21561959</pmid><doi>10.1177/1352458511402410</doi><tpages>8</tpages></addata></record> |
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| ispartof | Multiple sclerosis, 2011-08, Vol.17 (8), p.1002-1009 |
| issn | 1352-4585 1477-0970 |
| language | eng |
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| source | MEDLINE; SAGE Complete |
| subjects | Adult Benzhydryl Compounds - therapeutic use Biological and medical sciences Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases Double-Blind Method Fatigue - drug therapy Fatigue - etiology Female Humans Male Medical sciences Multiple Sclerosis - complications Multiple Sclerosis - drug therapy Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis Neurology Neuroprotective Agents - therapeutic use |
| title | HAGIL (Hamburg Vigil Study): a randomized placebo-controlled double-blind study with modafinil for treatment of fatigue in patients with multiple sclerosis |
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