Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial
ABSTRACT Introduction: Rasagiline is a monoamine oxidase B (MAO‐B) inhibitor with possible neuroprotective effects in patients with amyotrophic lateral sclerosis (ALS). Methods: We performed a randomized, double‐blind, placebo‐controlled trial of 80 ALS participants with enrichment of the placebo gr...
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| creator | Statland, Jeffrey M. Moore, Dan Wang, Yunxia Walsh, Maureen Mozaffar, Tahseen Elman, Lauren Nations, Sharon P. Mitsumoto, Hiroshi Fernandes, J. Americo Saperstein, David Hayat, Ghazala Herbelin, Laura Karam, Chafic Katz, Jonathan Wilkins, Heather M. Agbas, Abdulbaki Swerdlow, Russell H. Santella, Regina M. Dimachkie, Mazen M. Barohn, Richard J. Barohn, Richard J. Swerdlow, Russell Wang, Yunxia Statland, Jeffrey Dimachkie, Mazen M. Glenn, Melanie Pasnoor, Mamatha Walsh, Maureen Emmons, Kelley Johns, Kathryn Harness, Yolanda Herbelin, Laura Katz, Jonathan Miller, Robert G Forshew, Dallas Engel, Marguerite Mozaffar, Tahseen Goyal, Namita Cash, Tiyonnoh Mathew, Veena Martin, Veronica Saperstein, David Levine, Todd Flynne, Lynn Karam, Chafic Dimtrov, Diana Elman, Lauren McCluskey, Leo Almasy, Kelly Kelley, Mary Fernandes, J. Americo M. Thaisetthawatkul, Pariwat Peterson, Carolyn Cowardin, Cindy Heires, Peggy Nations, Sharon Trivedi, Jaya Gorham, Nina F. Hopkins, Steve Hayat, Ghazala Brown, Susan Mitsumoto, Hiroshi Aziz‐Zaman, Sonya Hupf, Jonathan Armstrong, Nicole McHale, Brittany Wilkins, Heather Agbas, Abdulbaki Sage, Jessica Hall, Sharice Santella, Regina Gurvich, Irina Amato, Anthony Bedlack, Richard Jackson, Carlayne Cutter, Gary Wolfe, Gil Simpson, Ericka |
| description | ABSTRACT
Introduction: Rasagiline is a monoamine oxidase B (MAO‐B) inhibitor with possible neuroprotective effects in patients with amyotrophic lateral sclerosis (ALS). Methods: We performed a randomized, double‐blind, placebo‐controlled trial of 80 ALS participants with enrichment of the placebo group with historical controls (n = 177) at 10 centers in the United States. Participants were randomized in a 3:1 ratio to 2 mg/day rasagiline or placebo. The primary outcome was average slope of decline on the ALS Functional Rating Scale—Revised (ALSFRS‐R). Secondary measures included slow vital capacity, survival, mitochondrial and molecular biomarkers, and adverse‐event reporting. Results: There was no difference in the average 12‐month ALSFRS‐R slope between rasagiline and the mixed placebo and historical control cohorts. Rasagiline did not show signs of drug‐target engagement in urine and blood biomarkers. Rasagiline was well tolerated with no serious adverse events. Discussion: Rasagiline did not alter disease progression compared with controls over 12 months of treatment. Muscle Nerve 59:201–207, 2019 |
| doi_str_mv | 10.1002/mus.26335 |
| format | Article |
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Introduction: Rasagiline is a monoamine oxidase B (MAO‐B) inhibitor with possible neuroprotective effects in patients with amyotrophic lateral sclerosis (ALS). Methods: We performed a randomized, double‐blind, placebo‐controlled trial of 80 ALS participants with enrichment of the placebo group with historical controls (n = 177) at 10 centers in the United States. Participants were randomized in a 3:1 ratio to 2 mg/day rasagiline or placebo. The primary outcome was average slope of decline on the ALS Functional Rating Scale—Revised (ALSFRS‐R). Secondary measures included slow vital capacity, survival, mitochondrial and molecular biomarkers, and adverse‐event reporting. Results: There was no difference in the average 12‐month ALSFRS‐R slope between rasagiline and the mixed placebo and historical control cohorts. Rasagiline did not show signs of drug‐target engagement in urine and blood biomarkers. Rasagiline was well tolerated with no serious adverse events. Discussion: Rasagiline did not alter disease progression compared with controls over 12 months of treatment. Muscle Nerve 59:201–207, 2019</description><identifier>ISSN: 0148-639X</identifier><identifier>EISSN: 1097-4598</identifier><identifier>DOI: 10.1002/mus.26335</identifier><identifier>PMID: 30192007</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Amine oxidase (flavin-containing) ; Amyotrophic lateral sclerosis ; Amyotrophic Lateral Sclerosis - drug therapy ; Amyotrophic Lateral Sclerosis - psychology ; biomarker ; Biomarkers ; controlled clinical trial ; Disease control ; DNA-Binding Proteins - metabolism ; Double-Blind Method ; Female ; Humans ; Indans - therapeutic use ; Male ; MAO‐B inhibitor ; Middle Aged ; Mitochondria ; motor neuron disease ; Motor neurone disease ; Muscles ; Neuroprotection ; Neuroprotective Agents - therapeutic use ; Outcome Assessment, Health Care ; Quality of Life ; Randomization ; randomized ; Rasagiline ; Retrospective Studies ; Severity of Illness Index ; Treatment Outcome ; United States ; Urine ; Young Adult</subject><ispartof>Muscle & nerve, 2019-02, Vol.59 (2), p.201-207</ispartof><rights>2018 Wiley Periodicals, Inc.</rights><rights>2019 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5095-de4a5e4c463ac517c536c0588a8f01b7d2c574ef9363989825f8dda64dbed7b53</citedby><cites>FETCH-LOGICAL-c5095-de4a5e4c463ac517c536c0588a8f01b7d2c574ef9363989825f8dda64dbed7b53</cites><orcidid>0000-0003-0790-5315</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fmus.26335$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fmus.26335$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30192007$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Statland, Jeffrey M.</creatorcontrib><creatorcontrib>Moore, Dan</creatorcontrib><creatorcontrib>Wang, Yunxia</creatorcontrib><creatorcontrib>Walsh, Maureen</creatorcontrib><creatorcontrib>Mozaffar, Tahseen</creatorcontrib><creatorcontrib>Elman, Lauren</creatorcontrib><creatorcontrib>Nations, Sharon P.</creatorcontrib><creatorcontrib>Mitsumoto, Hiroshi</creatorcontrib><creatorcontrib>Fernandes, J. 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Americo M.</creatorcontrib><creatorcontrib>Thaisetthawatkul, Pariwat</creatorcontrib><creatorcontrib>Peterson, Carolyn</creatorcontrib><creatorcontrib>Cowardin, Cindy</creatorcontrib><creatorcontrib>Heires, Peggy</creatorcontrib><creatorcontrib>Nations, Sharon</creatorcontrib><creatorcontrib>Trivedi, Jaya</creatorcontrib><creatorcontrib>Gorham, Nina F.</creatorcontrib><creatorcontrib>Hopkins, Steve</creatorcontrib><creatorcontrib>Hayat, Ghazala</creatorcontrib><creatorcontrib>Brown, Susan</creatorcontrib><creatorcontrib>Mitsumoto, Hiroshi</creatorcontrib><creatorcontrib>Aziz‐Zaman, Sonya</creatorcontrib><creatorcontrib>Hupf, Jonathan</creatorcontrib><creatorcontrib>Armstrong, Nicole</creatorcontrib><creatorcontrib>McHale, Brittany</creatorcontrib><creatorcontrib>Wilkins, Heather</creatorcontrib><creatorcontrib>Agbas, Abdulbaki</creatorcontrib><creatorcontrib>Sage, Jessica</creatorcontrib><creatorcontrib>Hall, Sharice</creatorcontrib><creatorcontrib>Santella, Regina</creatorcontrib><creatorcontrib>Gurvich, Irina</creatorcontrib><creatorcontrib>Amato, Anthony</creatorcontrib><creatorcontrib>Bedlack, Richard</creatorcontrib><creatorcontrib>Jackson, Carlayne</creatorcontrib><creatorcontrib>Cutter, Gary</creatorcontrib><creatorcontrib>Wolfe, Gil</creatorcontrib><creatorcontrib>Simpson, Ericka</creatorcontrib><creatorcontrib>Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium</creatorcontrib><creatorcontrib>The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium</creatorcontrib><title>Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial</title><title>Muscle & nerve</title><addtitle>Muscle Nerve</addtitle><description>ABSTRACT
Introduction: Rasagiline is a monoamine oxidase B (MAO‐B) inhibitor with possible neuroprotective effects in patients with amyotrophic lateral sclerosis (ALS). Methods: We performed a randomized, double‐blind, placebo‐controlled trial of 80 ALS participants with enrichment of the placebo group with historical controls (n = 177) at 10 centers in the United States. Participants were randomized in a 3:1 ratio to 2 mg/day rasagiline or placebo. The primary outcome was average slope of decline on the ALS Functional Rating Scale—Revised (ALSFRS‐R). Secondary measures included slow vital capacity, survival, mitochondrial and molecular biomarkers, and adverse‐event reporting. Results: There was no difference in the average 12‐month ALSFRS‐R slope between rasagiline and the mixed placebo and historical control cohorts. Rasagiline did not show signs of drug‐target engagement in urine and blood biomarkers. Rasagiline was well tolerated with no serious adverse events. Discussion: Rasagiline did not alter disease progression compared with controls over 12 months of treatment. Muscle Nerve 59:201–207, 2019</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amine oxidase (flavin-containing)</subject><subject>Amyotrophic lateral sclerosis</subject><subject>Amyotrophic Lateral Sclerosis - drug therapy</subject><subject>Amyotrophic Lateral Sclerosis - psychology</subject><subject>biomarker</subject><subject>Biomarkers</subject><subject>controlled clinical trial</subject><subject>Disease control</subject><subject>DNA-Binding Proteins - metabolism</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Indans - therapeutic use</subject><subject>Male</subject><subject>MAO‐B inhibitor</subject><subject>Middle Aged</subject><subject>Mitochondria</subject><subject>motor neuron disease</subject><subject>Motor neurone disease</subject><subject>Muscles</subject><subject>Neuroprotection</subject><subject>Neuroprotective Agents - therapeutic use</subject><subject>Outcome Assessment, Health Care</subject><subject>Quality of Life</subject><subject>Randomization</subject><subject>randomized</subject><subject>Rasagiline</subject><subject>Retrospective Studies</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>Urine</subject><subject>Young Adult</subject><issn>0148-639X</issn><issn>1097-4598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kM1KAzEURoMotlYXvoAMuBKcNplMMhkXQin-QUVQC-5CmmTalMykJq1Sn95oa9GFq7u4h3O_-wFwjGAXQZj16mXoZhRjsgPaCJZFmpOS7YI2RDlLKS5fWuAghBmEEDFa7IMWhqjMICzaYPgogpgYaxqdVM4nol65hXfzqZGJFQvthU2CtNq7YMJF0k-8aJSrzYdW54l0TWSt1SpZeCPsIdirhA36aDM7YHR99Ty4TYcPN3eD_jCVBJYkVToXROcyp1hIggpJMJWQMCZYBdG4UJkkRa6rEsfsrGQZqZhSguZqrFUxJrgDLtfe-XJcayV1jCEsn3tTC7_iThj-d9OYKZ-4N05JTrJo7YDTjcC716UOCz5zS9_EzDxDlBWMUYgjdbamZPw-eF1tLyDIv4rnsXj-XXxkT35H2pI_TUegtwbejdWr_038fvS0Vn4CJTyOww</recordid><startdate>201902</startdate><enddate>201902</enddate><creator>Statland, Jeffrey M.</creator><creator>Moore, Dan</creator><creator>Wang, Yunxia</creator><creator>Walsh, Maureen</creator><creator>Mozaffar, Tahseen</creator><creator>Elman, Lauren</creator><creator>Nations, Sharon P.</creator><creator>Mitsumoto, Hiroshi</creator><creator>Fernandes, J. 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Americo ; Saperstein, David ; Hayat, Ghazala ; Herbelin, Laura ; Karam, Chafic ; Katz, Jonathan ; Wilkins, Heather M. ; Agbas, Abdulbaki ; Swerdlow, Russell H. ; Santella, Regina M. ; Dimachkie, Mazen M. ; Barohn, Richard J. ; Barohn, Richard J. ; Swerdlow, Russell ; Wang, Yunxia ; Statland, Jeffrey ; Dimachkie, Mazen M. ; Glenn, Melanie ; Pasnoor, Mamatha ; Walsh, Maureen ; Emmons, Kelley ; Johns, Kathryn ; Harness, Yolanda ; Herbelin, Laura ; Katz, Jonathan ; Miller, Robert G ; Forshew, Dallas ; Engel, Marguerite ; Mozaffar, Tahseen ; Goyal, Namita ; Cash, Tiyonnoh ; Mathew, Veena ; Martin, Veronica ; Saperstein, David ; Levine, Todd ; Flynne, Lynn ; Karam, Chafic ; Dimtrov, Diana ; Elman, Lauren ; McCluskey, Leo ; Almasy, Kelly ; Kelley, Mary ; Fernandes, J. Americo M. ; Thaisetthawatkul, Pariwat ; Peterson, Carolyn ; Cowardin, Cindy ; Heires, Peggy ; Nations, Sharon ; Trivedi, Jaya ; Gorham, Nina F. ; Hopkins, Steve ; Hayat, Ghazala ; Brown, Susan ; Mitsumoto, Hiroshi ; Aziz‐Zaman, Sonya ; Hupf, Jonathan ; Armstrong, Nicole ; McHale, Brittany ; Wilkins, Heather ; Agbas, Abdulbaki ; Sage, Jessica ; Hall, Sharice ; Santella, Regina ; Gurvich, Irina ; Amato, Anthony ; Bedlack, Richard ; Jackson, Carlayne ; Cutter, Gary ; Wolfe, Gil ; Simpson, Ericka</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5095-de4a5e4c463ac517c536c0588a8f01b7d2c574ef9363989825f8dda64dbed7b53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amine oxidase (flavin-containing)</topic><topic>Amyotrophic lateral sclerosis</topic><topic>Amyotrophic Lateral Sclerosis - drug therapy</topic><topic>Amyotrophic Lateral Sclerosis - psychology</topic><topic>biomarker</topic><topic>Biomarkers</topic><topic>controlled clinical trial</topic><topic>Disease control</topic><topic>DNA-Binding Proteins - metabolism</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Indans - therapeutic use</topic><topic>Male</topic><topic>MAO‐B inhibitor</topic><topic>Middle Aged</topic><topic>Mitochondria</topic><topic>motor neuron disease</topic><topic>Motor neurone disease</topic><topic>Muscles</topic><topic>Neuroprotection</topic><topic>Neuroprotective Agents - therapeutic use</topic><topic>Outcome Assessment, Health Care</topic><topic>Quality of Life</topic><topic>Randomization</topic><topic>randomized</topic><topic>Rasagiline</topic><topic>Retrospective Studies</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><topic>United States</topic><topic>Urine</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Statland, Jeffrey M.</creatorcontrib><creatorcontrib>Moore, Dan</creatorcontrib><creatorcontrib>Wang, Yunxia</creatorcontrib><creatorcontrib>Walsh, Maureen</creatorcontrib><creatorcontrib>Mozaffar, Tahseen</creatorcontrib><creatorcontrib>Elman, Lauren</creatorcontrib><creatorcontrib>Nations, Sharon P.</creatorcontrib><creatorcontrib>Mitsumoto, Hiroshi</creatorcontrib><creatorcontrib>Fernandes, J. Americo</creatorcontrib><creatorcontrib>Saperstein, David</creatorcontrib><creatorcontrib>Hayat, Ghazala</creatorcontrib><creatorcontrib>Herbelin, Laura</creatorcontrib><creatorcontrib>Karam, Chafic</creatorcontrib><creatorcontrib>Katz, Jonathan</creatorcontrib><creatorcontrib>Wilkins, Heather M.</creatorcontrib><creatorcontrib>Agbas, Abdulbaki</creatorcontrib><creatorcontrib>Swerdlow, Russell H.</creatorcontrib><creatorcontrib>Santella, Regina M.</creatorcontrib><creatorcontrib>Dimachkie, Mazen M.</creatorcontrib><creatorcontrib>Barohn, Richard J.</creatorcontrib><creatorcontrib>Barohn, Richard J.</creatorcontrib><creatorcontrib>Swerdlow, Russell</creatorcontrib><creatorcontrib>Wang, Yunxia</creatorcontrib><creatorcontrib>Statland, Jeffrey</creatorcontrib><creatorcontrib>Dimachkie, Mazen M.</creatorcontrib><creatorcontrib>Glenn, Melanie</creatorcontrib><creatorcontrib>Pasnoor, Mamatha</creatorcontrib><creatorcontrib>Walsh, Maureen</creatorcontrib><creatorcontrib>Emmons, Kelley</creatorcontrib><creatorcontrib>Johns, Kathryn</creatorcontrib><creatorcontrib>Harness, Yolanda</creatorcontrib><creatorcontrib>Herbelin, Laura</creatorcontrib><creatorcontrib>Katz, Jonathan</creatorcontrib><creatorcontrib>Miller, Robert G</creatorcontrib><creatorcontrib>Forshew, Dallas</creatorcontrib><creatorcontrib>Engel, Marguerite</creatorcontrib><creatorcontrib>Mozaffar, Tahseen</creatorcontrib><creatorcontrib>Goyal, Namita</creatorcontrib><creatorcontrib>Cash, Tiyonnoh</creatorcontrib><creatorcontrib>Mathew, Veena</creatorcontrib><creatorcontrib>Martin, Veronica</creatorcontrib><creatorcontrib>Saperstein, David</creatorcontrib><creatorcontrib>Levine, Todd</creatorcontrib><creatorcontrib>Flynne, Lynn</creatorcontrib><creatorcontrib>Karam, Chafic</creatorcontrib><creatorcontrib>Dimtrov, Diana</creatorcontrib><creatorcontrib>Elman, Lauren</creatorcontrib><creatorcontrib>McCluskey, Leo</creatorcontrib><creatorcontrib>Almasy, Kelly</creatorcontrib><creatorcontrib>Kelley, Mary</creatorcontrib><creatorcontrib>Fernandes, J. Americo M.</creatorcontrib><creatorcontrib>Thaisetthawatkul, Pariwat</creatorcontrib><creatorcontrib>Peterson, Carolyn</creatorcontrib><creatorcontrib>Cowardin, Cindy</creatorcontrib><creatorcontrib>Heires, Peggy</creatorcontrib><creatorcontrib>Nations, Sharon</creatorcontrib><creatorcontrib>Trivedi, Jaya</creatorcontrib><creatorcontrib>Gorham, Nina F.</creatorcontrib><creatorcontrib>Hopkins, Steve</creatorcontrib><creatorcontrib>Hayat, Ghazala</creatorcontrib><creatorcontrib>Brown, Susan</creatorcontrib><creatorcontrib>Mitsumoto, Hiroshi</creatorcontrib><creatorcontrib>Aziz‐Zaman, Sonya</creatorcontrib><creatorcontrib>Hupf, Jonathan</creatorcontrib><creatorcontrib>Armstrong, Nicole</creatorcontrib><creatorcontrib>McHale, Brittany</creatorcontrib><creatorcontrib>Wilkins, Heather</creatorcontrib><creatorcontrib>Agbas, Abdulbaki</creatorcontrib><creatorcontrib>Sage, Jessica</creatorcontrib><creatorcontrib>Hall, Sharice</creatorcontrib><creatorcontrib>Santella, Regina</creatorcontrib><creatorcontrib>Gurvich, Irina</creatorcontrib><creatorcontrib>Amato, Anthony</creatorcontrib><creatorcontrib>Bedlack, Richard</creatorcontrib><creatorcontrib>Jackson, Carlayne</creatorcontrib><creatorcontrib>Cutter, Gary</creatorcontrib><creatorcontrib>Wolfe, Gil</creatorcontrib><creatorcontrib>Simpson, Ericka</creatorcontrib><creatorcontrib>Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium</creatorcontrib><creatorcontrib>The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Muscle & nerve</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Statland, Jeffrey M.</au><au>Moore, Dan</au><au>Wang, Yunxia</au><au>Walsh, Maureen</au><au>Mozaffar, Tahseen</au><au>Elman, Lauren</au><au>Nations, Sharon P.</au><au>Mitsumoto, Hiroshi</au><au>Fernandes, J. Americo</au><au>Saperstein, David</au><au>Hayat, Ghazala</au><au>Herbelin, Laura</au><au>Karam, Chafic</au><au>Katz, Jonathan</au><au>Wilkins, Heather M.</au><au>Agbas, Abdulbaki</au><au>Swerdlow, Russell H.</au><au>Santella, Regina M.</au><au>Dimachkie, Mazen M.</au><au>Barohn, Richard J.</au><au>Barohn, Richard J.</au><au>Swerdlow, Russell</au><au>Wang, Yunxia</au><au>Statland, Jeffrey</au><au>Dimachkie, Mazen M.</au><au>Glenn, Melanie</au><au>Pasnoor, Mamatha</au><au>Walsh, Maureen</au><au>Emmons, Kelley</au><au>Johns, Kathryn</au><au>Harness, Yolanda</au><au>Herbelin, Laura</au><au>Katz, Jonathan</au><au>Miller, Robert G</au><au>Forshew, Dallas</au><au>Engel, Marguerite</au><au>Mozaffar, Tahseen</au><au>Goyal, Namita</au><au>Cash, Tiyonnoh</au><au>Mathew, Veena</au><au>Martin, Veronica</au><au>Saperstein, David</au><au>Levine, Todd</au><au>Flynne, Lynn</au><au>Karam, Chafic</au><au>Dimtrov, Diana</au><au>Elman, Lauren</au><au>McCluskey, Leo</au><au>Almasy, Kelly</au><au>Kelley, Mary</au><au>Fernandes, J. Americo M.</au><au>Thaisetthawatkul, Pariwat</au><au>Peterson, Carolyn</au><au>Cowardin, Cindy</au><au>Heires, Peggy</au><au>Nations, Sharon</au><au>Trivedi, Jaya</au><au>Gorham, Nina F.</au><au>Hopkins, Steve</au><au>Hayat, Ghazala</au><au>Brown, Susan</au><au>Mitsumoto, Hiroshi</au><au>Aziz‐Zaman, Sonya</au><au>Hupf, Jonathan</au><au>Armstrong, Nicole</au><au>McHale, Brittany</au><au>Wilkins, Heather</au><au>Agbas, Abdulbaki</au><au>Sage, Jessica</au><au>Hall, Sharice</au><au>Santella, Regina</au><au>Gurvich, Irina</au><au>Amato, Anthony</au><au>Bedlack, Richard</au><au>Jackson, Carlayne</au><au>Cutter, Gary</au><au>Wolfe, Gil</au><au>Simpson, Ericka</au><aucorp>Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium</aucorp><aucorp>The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial</atitle><jtitle>Muscle & nerve</jtitle><addtitle>Muscle Nerve</addtitle><date>2019-02</date><risdate>2019</risdate><volume>59</volume><issue>2</issue><spage>201</spage><epage>207</epage><pages>201-207</pages><issn>0148-639X</issn><eissn>1097-4598</eissn><abstract>ABSTRACT
Introduction: Rasagiline is a monoamine oxidase B (MAO‐B) inhibitor with possible neuroprotective effects in patients with amyotrophic lateral sclerosis (ALS). Methods: We performed a randomized, double‐blind, placebo‐controlled trial of 80 ALS participants with enrichment of the placebo group with historical controls (n = 177) at 10 centers in the United States. Participants were randomized in a 3:1 ratio to 2 mg/day rasagiline or placebo. The primary outcome was average slope of decline on the ALS Functional Rating Scale—Revised (ALSFRS‐R). Secondary measures included slow vital capacity, survival, mitochondrial and molecular biomarkers, and adverse‐event reporting. Results: There was no difference in the average 12‐month ALSFRS‐R slope between rasagiline and the mixed placebo and historical control cohorts. Rasagiline did not show signs of drug‐target engagement in urine and blood biomarkers. Rasagiline was well tolerated with no serious adverse events. Discussion: Rasagiline did not alter disease progression compared with controls over 12 months of treatment. Muscle Nerve 59:201–207, 2019</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>30192007</pmid><doi>10.1002/mus.26335</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-0790-5315</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0148-639X |
| ispartof | Muscle & nerve, 2019-02, Vol.59 (2), p.201-207 |
| issn | 0148-639X 1097-4598 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6545236 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult Aged Aged, 80 and over Amine oxidase (flavin-containing) Amyotrophic lateral sclerosis Amyotrophic Lateral Sclerosis - drug therapy Amyotrophic Lateral Sclerosis - psychology biomarker Biomarkers controlled clinical trial Disease control DNA-Binding Proteins - metabolism Double-Blind Method Female Humans Indans - therapeutic use Male MAO‐B inhibitor Middle Aged Mitochondria motor neuron disease Motor neurone disease Muscles Neuroprotection Neuroprotective Agents - therapeutic use Outcome Assessment, Health Care Quality of Life Randomization randomized Rasagiline Retrospective Studies Severity of Illness Index Treatment Outcome United States Urine Young Adult |
| title | Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-06T17%3A55%3A45IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Rasagiline%20for%20amyotrophic%20lateral%20sclerosis:%20A%20randomized,%20controlled%20trial&rft.jtitle=Muscle%20&%20nerve&rft.au=Statland,%20Jeffrey%20M.&rft.aucorp=Rasagiline%20Investigators%20of%20the%20Muscle%20Study%20Group%20and%20Western%20ALS%20Consortium&rft.date=2019-02&rft.volume=59&rft.issue=2&rft.spage=201&rft.epage=207&rft.pages=201-207&rft.issn=0148-639X&rft.eissn=1097-4598&rft_id=info:doi/10.1002/mus.26335&rft_dat=%3Cproquest_pubme%3E2168788603%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2168788603&rft_id=info:pmid/30192007&rfr_iscdi=true |