Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study
ABSTRACT Background Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations. Objective Evaluate 1‐year safety data. Methods BeyoND is an open‐label study evaluating the long‐term...
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| Veröffentlicht in: | Movement disorders 2021-11, Vol.36 (11), p.2687-2692 |
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| creator | Poewe, Werner Stocchi, Fabrizio Arkadir, David Ebersbach, Georg Ellenbogen, Aaron L. Giladi, Nir Isaacson, Stuart H. Kieburtz, Karl LeWitt, Peter Olanow, C. Warren Simuni, Tanya Thomas, Astrid Zlotogorski, Abraham Adar, Liat Case, Ryan Oren, Sheila Fuchs Orenbach, Shir Rosenfeld, Olivia Sasson, Nissim Yardeni, Tami Espay, Alberto J. |
| description | ABSTRACT
Background
Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations.
Objective
Evaluate 1‐year safety data.
Methods
BeyoND is an open‐label study evaluating the long‐term safety of two ND0612 dosing regimens.
Results
Of the 214 enrolled patients (24‐hour SC infusion: n = 90; 16‐hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%). Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining. Systemic safety was typical for PD patients treated with levodopa/carbidopa. Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants.
Conclusions
Subcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society |
| doi_str_mv | 10.1002/mds.28758 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9291977</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2597693440</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5098-aec1ec17cd2803751965fd580975097336bf33d6396bf0d5b4530238fae25be13</originalsourceid><addsrcrecordid>eNp1kcFO3DAURa2KqkxpF_xAZYkFZRGw4zi2WSC1M7RFmpZKAwtWlpO8dEITe7AT0Oz4BL6RL6khFLWVKj3JT7pHV8_3IrRNyT4lJD3oqrCfSsHlCzShnNFEplxsoAmRkieMSr6JXodwSQilnOav0CbLMpUTSSdouRiKcuiNBTcEPIdrV7mVwSe2HkLjLK6dx9-N_9nY4OxuwLMmgAlwiOn97d0FGI9npje49q7D_RLw6QpsVOamgBZ_hLX7NsOLfqjWb9DL2rQB3j69W-j80_HZ9EsyP_18Mv0wT0pOlEwMlDSOKKtUEiY4VTmvKy6JElEXjOVFzViVMxUXUvEi44ykTNYGUl4AZVvoaPRdDUUHVQm296bVK990xq-1M43-W7HNUv9w11qliiohosH7JwPvrgYIve6aUELbjhnpGC0lmUrzLKI7_6CXbvA2fi9SSuQq5kwitTdSpXcheKifj6FEP_SnY3_6sb_Ivvvz-mfyd2EROBiBm6aF9f-d9NfZYrT8BUjBph4</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2597693440</pqid></control><display><type>article</type><title>Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Poewe, Werner ; Stocchi, Fabrizio ; Arkadir, David ; Ebersbach, Georg ; Ellenbogen, Aaron L. ; Giladi, Nir ; Isaacson, Stuart H. ; Kieburtz, Karl ; LeWitt, Peter ; Olanow, C. Warren ; Simuni, Tanya ; Thomas, Astrid ; Zlotogorski, Abraham ; Adar, Liat ; Case, Ryan ; Oren, Sheila ; Fuchs Orenbach, Shir ; Rosenfeld, Olivia ; Sasson, Nissim ; Yardeni, Tami ; Espay, Alberto J.</creator><creatorcontrib>Poewe, Werner ; Stocchi, Fabrizio ; Arkadir, David ; Ebersbach, Georg ; Ellenbogen, Aaron L. ; Giladi, Nir ; Isaacson, Stuart H. ; Kieburtz, Karl ; LeWitt, Peter ; Olanow, C. Warren ; Simuni, Tanya ; Thomas, Astrid ; Zlotogorski, Abraham ; Adar, Liat ; Case, Ryan ; Oren, Sheila ; Fuchs Orenbach, Shir ; Rosenfeld, Olivia ; Sasson, Nissim ; Yardeni, Tami ; Espay, Alberto J. ; BeyoND study group ; and for the BeyoND study group</creatorcontrib><description>ABSTRACT
Background
Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations.
Objective
Evaluate 1‐year safety data.
Methods
BeyoND is an open‐label study evaluating the long‐term safety of two ND0612 dosing regimens.
Results
Of the 214 enrolled patients (24‐hour SC infusion: n = 90; 16‐hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%). Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining. Systemic safety was typical for PD patients treated with levodopa/carbidopa. Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants.
Conclusions
Subcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society</description><identifier>ISSN: 0885-3185</identifier><identifier>EISSN: 1531-8257</identifier><identifier>DOI: 10.1002/mds.28758</identifier><identifier>PMID: 34496081</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Adverse events ; Antiparkinson Agents - adverse effects ; Brief Report ; Carbidopa - adverse effects ; Drug Combinations ; Gels ; Hematoma ; Humans ; infusion ; Levodopa ; Levodopa - adverse effects ; Movement disorders ; ND0612 ; Neurodegenerative diseases ; Parkinson Disease - drug therapy ; Parkinson's disease ; Patients ; Regular Issue ; Safety ; subcutaneous</subject><ispartof>Movement disorders, 2021-11, Vol.36 (11), p.2687-2692</ispartof><rights>2021 The Authors. published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society</rights><rights>2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.</rights><rights>2021. This article is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5098-aec1ec17cd2803751965fd580975097336bf33d6396bf0d5b4530238fae25be13</citedby><cites>FETCH-LOGICAL-c5098-aec1ec17cd2803751965fd580975097336bf33d6396bf0d5b4530238fae25be13</cites><orcidid>0000-0002-5922-2041 ; 0000-0001-5471-1471 ; 0000-0002-3389-136X</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%2Fmds.28758$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fmds.28758$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34496081$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Poewe, Werner</creatorcontrib><creatorcontrib>Stocchi, Fabrizio</creatorcontrib><creatorcontrib>Arkadir, David</creatorcontrib><creatorcontrib>Ebersbach, Georg</creatorcontrib><creatorcontrib>Ellenbogen, Aaron L.</creatorcontrib><creatorcontrib>Giladi, Nir</creatorcontrib><creatorcontrib>Isaacson, Stuart H.</creatorcontrib><creatorcontrib>Kieburtz, Karl</creatorcontrib><creatorcontrib>LeWitt, Peter</creatorcontrib><creatorcontrib>Olanow, C. Warren</creatorcontrib><creatorcontrib>Simuni, Tanya</creatorcontrib><creatorcontrib>Thomas, Astrid</creatorcontrib><creatorcontrib>Zlotogorski, Abraham</creatorcontrib><creatorcontrib>Adar, Liat</creatorcontrib><creatorcontrib>Case, Ryan</creatorcontrib><creatorcontrib>Oren, Sheila</creatorcontrib><creatorcontrib>Fuchs Orenbach, Shir</creatorcontrib><creatorcontrib>Rosenfeld, Olivia</creatorcontrib><creatorcontrib>Sasson, Nissim</creatorcontrib><creatorcontrib>Yardeni, Tami</creatorcontrib><creatorcontrib>Espay, Alberto J.</creatorcontrib><creatorcontrib>BeyoND study group</creatorcontrib><creatorcontrib>and for the BeyoND study group</creatorcontrib><title>Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study</title><title>Movement disorders</title><addtitle>Mov Disord</addtitle><description>ABSTRACT
Background
Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations.
Objective
Evaluate 1‐year safety data.
Methods
BeyoND is an open‐label study evaluating the long‐term safety of two ND0612 dosing regimens.
Results
Of the 214 enrolled patients (24‐hour SC infusion: n = 90; 16‐hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%). Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining. Systemic safety was typical for PD patients treated with levodopa/carbidopa. Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants.
Conclusions
Subcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society</description><subject>Adverse events</subject><subject>Antiparkinson Agents - adverse effects</subject><subject>Brief Report</subject><subject>Carbidopa - adverse effects</subject><subject>Drug Combinations</subject><subject>Gels</subject><subject>Hematoma</subject><subject>Humans</subject><subject>infusion</subject><subject>Levodopa</subject><subject>Levodopa - adverse effects</subject><subject>Movement disorders</subject><subject>ND0612</subject><subject>Neurodegenerative diseases</subject><subject>Parkinson Disease - drug therapy</subject><subject>Parkinson's disease</subject><subject>Patients</subject><subject>Regular Issue</subject><subject>Safety</subject><subject>subcutaneous</subject><issn>0885-3185</issn><issn>1531-8257</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kcFO3DAURa2KqkxpF_xAZYkFZRGw4zi2WSC1M7RFmpZKAwtWlpO8dEITe7AT0Oz4BL6RL6khFLWVKj3JT7pHV8_3IrRNyT4lJD3oqrCfSsHlCzShnNFEplxsoAmRkieMSr6JXodwSQilnOav0CbLMpUTSSdouRiKcuiNBTcEPIdrV7mVwSe2HkLjLK6dx9-N_9nY4OxuwLMmgAlwiOn97d0FGI9npje49q7D_RLw6QpsVOamgBZ_hLX7NsOLfqjWb9DL2rQB3j69W-j80_HZ9EsyP_18Mv0wT0pOlEwMlDSOKKtUEiY4VTmvKy6JElEXjOVFzViVMxUXUvEi44ykTNYGUl4AZVvoaPRdDUUHVQm296bVK990xq-1M43-W7HNUv9w11qliiohosH7JwPvrgYIve6aUELbjhnpGC0lmUrzLKI7_6CXbvA2fi9SSuQq5kwitTdSpXcheKifj6FEP_SnY3_6sb_Ivvvz-mfyd2EROBiBm6aF9f-d9NfZYrT8BUjBph4</recordid><startdate>202111</startdate><enddate>202111</enddate><creator>Poewe, Werner</creator><creator>Stocchi, Fabrizio</creator><creator>Arkadir, David</creator><creator>Ebersbach, Georg</creator><creator>Ellenbogen, Aaron L.</creator><creator>Giladi, Nir</creator><creator>Isaacson, Stuart H.</creator><creator>Kieburtz, Karl</creator><creator>LeWitt, Peter</creator><creator>Olanow, C. Warren</creator><creator>Simuni, Tanya</creator><creator>Thomas, Astrid</creator><creator>Zlotogorski, Abraham</creator><creator>Adar, Liat</creator><creator>Case, Ryan</creator><creator>Oren, Sheila</creator><creator>Fuchs Orenbach, Shir</creator><creator>Rosenfeld, Olivia</creator><creator>Sasson, Nissim</creator><creator>Yardeni, Tami</creator><creator>Espay, Alberto J.</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>24P</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>7TK</scope><scope>8FD</scope><scope>FR3</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-5922-2041</orcidid><orcidid>https://orcid.org/0000-0001-5471-1471</orcidid><orcidid>https://orcid.org/0000-0002-3389-136X</orcidid></search><sort><creationdate>202111</creationdate><title>Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study</title><author>Poewe, Werner ; Stocchi, Fabrizio ; Arkadir, David ; Ebersbach, Georg ; Ellenbogen, Aaron L. ; Giladi, Nir ; Isaacson, Stuart H. ; Kieburtz, Karl ; LeWitt, Peter ; Olanow, C. Warren ; Simuni, Tanya ; Thomas, Astrid ; Zlotogorski, Abraham ; Adar, Liat ; Case, Ryan ; Oren, Sheila ; Fuchs Orenbach, Shir ; Rosenfeld, Olivia ; Sasson, Nissim ; Yardeni, Tami ; Espay, Alberto J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5098-aec1ec17cd2803751965fd580975097336bf33d6396bf0d5b4530238fae25be13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Antiparkinson Agents - adverse effects</topic><topic>Brief Report</topic><topic>Carbidopa - adverse effects</topic><topic>Drug Combinations</topic><topic>Gels</topic><topic>Hematoma</topic><topic>Humans</topic><topic>infusion</topic><topic>Levodopa</topic><topic>Levodopa - adverse effects</topic><topic>Movement disorders</topic><topic>ND0612</topic><topic>Neurodegenerative diseases</topic><topic>Parkinson Disease - drug therapy</topic><topic>Parkinson's disease</topic><topic>Patients</topic><topic>Regular Issue</topic><topic>Safety</topic><topic>subcutaneous</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Poewe, Werner</creatorcontrib><creatorcontrib>Stocchi, Fabrizio</creatorcontrib><creatorcontrib>Arkadir, David</creatorcontrib><creatorcontrib>Ebersbach, Georg</creatorcontrib><creatorcontrib>Ellenbogen, Aaron L.</creatorcontrib><creatorcontrib>Giladi, Nir</creatorcontrib><creatorcontrib>Isaacson, Stuart H.</creatorcontrib><creatorcontrib>Kieburtz, Karl</creatorcontrib><creatorcontrib>LeWitt, Peter</creatorcontrib><creatorcontrib>Olanow, C. Warren</creatorcontrib><creatorcontrib>Simuni, Tanya</creatorcontrib><creatorcontrib>Thomas, Astrid</creatorcontrib><creatorcontrib>Zlotogorski, Abraham</creatorcontrib><creatorcontrib>Adar, Liat</creatorcontrib><creatorcontrib>Case, Ryan</creatorcontrib><creatorcontrib>Oren, Sheila</creatorcontrib><creatorcontrib>Fuchs Orenbach, Shir</creatorcontrib><creatorcontrib>Rosenfeld, Olivia</creatorcontrib><creatorcontrib>Sasson, Nissim</creatorcontrib><creatorcontrib>Yardeni, Tami</creatorcontrib><creatorcontrib>Espay, Alberto J.</creatorcontrib><creatorcontrib>BeyoND study group</creatorcontrib><creatorcontrib>and for the BeyoND study group</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Movement disorders</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Poewe, Werner</au><au>Stocchi, Fabrizio</au><au>Arkadir, David</au><au>Ebersbach, Georg</au><au>Ellenbogen, Aaron L.</au><au>Giladi, Nir</au><au>Isaacson, Stuart H.</au><au>Kieburtz, Karl</au><au>LeWitt, Peter</au><au>Olanow, C. Warren</au><au>Simuni, Tanya</au><au>Thomas, Astrid</au><au>Zlotogorski, Abraham</au><au>Adar, Liat</au><au>Case, Ryan</au><au>Oren, Sheila</au><au>Fuchs Orenbach, Shir</au><au>Rosenfeld, Olivia</au><au>Sasson, Nissim</au><au>Yardeni, Tami</au><au>Espay, Alberto J.</au><aucorp>BeyoND study group</aucorp><aucorp>and for the BeyoND study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study</atitle><jtitle>Movement disorders</jtitle><addtitle>Mov Disord</addtitle><date>2021-11</date><risdate>2021</risdate><volume>36</volume><issue>11</issue><spage>2687</spage><epage>2692</epage><pages>2687-2692</pages><issn>0885-3185</issn><eissn>1531-8257</eissn><abstract>ABSTRACT
Background
Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations.
Objective
Evaluate 1‐year safety data.
Methods
BeyoND is an open‐label study evaluating the long‐term safety of two ND0612 dosing regimens.
Results
Of the 214 enrolled patients (24‐hour SC infusion: n = 90; 16‐hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%). Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining. Systemic safety was typical for PD patients treated with levodopa/carbidopa. Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants.
Conclusions
Subcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>34496081</pmid><doi>10.1002/mds.28758</doi><tpages>36</tpages><orcidid>https://orcid.org/0000-0002-5922-2041</orcidid><orcidid>https://orcid.org/0000-0001-5471-1471</orcidid><orcidid>https://orcid.org/0000-0002-3389-136X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0885-3185 |
| ispartof | Movement disorders, 2021-11, Vol.36 (11), p.2687-2692 |
| issn | 0885-3185 1531-8257 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adverse events Antiparkinson Agents - adverse effects Brief Report Carbidopa - adverse effects Drug Combinations Gels Hematoma Humans infusion Levodopa Levodopa - adverse effects Movement disorders ND0612 Neurodegenerative diseases Parkinson Disease - drug therapy Parkinson's disease Patients Regular Issue Safety subcutaneous |
| title | Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study |
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