Randomized, placebo‐controlled trial of ADS‐5102 (amantadine) extended‐release capsules for levodopa‐induced dyskinesia in Parkinson's disease (EASE LID 3)
ABSTRACT Background The treatment of levodopa‐induced dyskinesia in Parkinson's disease (PD) is an unmet need with no approved drug therapy. Objective The purpose of this study was to investigate the efficacy and safety of 274 mg ADS‐5102 (amantadine) extended‐release capsules (equivalent to 34...
Gespeichert in:
| Veröffentlicht in: | Movement disorders 2017-12, Vol.32 (12), p.1701-1709 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1709 |
|---|---|
| container_issue | 12 |
| container_start_page | 1701 |
| container_title | Movement disorders |
| container_volume | 32 |
| creator | Oertel, Wolfgang Eggert, Karla Pahwa, Rajesh Tanner, Caroline M. Hauser, Robert A. Trenkwalder, Claudia Ehret, Reinhard Azulay, Jean Philippe Isaacson, Stuart Felt, Larissa Stempien, Mary Jean |
| description | ABSTRACT
Background
The treatment of levodopa‐induced dyskinesia in Parkinson's disease (PD) is an unmet need with no approved drug therapy.
Objective
The purpose of this study was to investigate the efficacy and safety of 274 mg ADS‐5102 (amantadine) extended‐release capsules (equivalent to 340‐mg amantadine HCl) for levodopa‐induced dyskinesia in a randomized controlled trial.
Methods
PD patients with ≥1 hour of troublesome dyskinesia and at least mild functional impact were randomized to placebo or ADS‐5102 once daily at bedtime for 13 weeks. The primary efficacy analysis was based on change from baseline to week 12 on the Unified Dyskinesia Rating Scale total score in the modified intent‐to‐treat population. OFF time was a key secondary measure.
Results
At week 12, least‐squares mean change in the Unified Dyskinesia Rating Scale was −20.7 (standard error 2.2) for ADS‐5102 (n = 37) and –6.3 (standard error 2.1) for placebo (n = 38; treatment difference −14.4, 95% confidence interval −20.4 to −8.3, P < .0001), indicating improvement in levodopa‐induced dyskinesia. OFF time decreased 0.5 hours (standard error 0.3) for ADS‐5102 from a baseline mean of 2.6 hours and increased 0.6 hours (standard error 0.3) for placebo from a baseline mean of 2.0 hours (treatment difference −1.1 hours, 95% confidence interval −2.0 to −0.2, P = .0199). The most common adverse events (ADS‐5102 versus placebo) included dry mouth (13.5% versus 2.6%), nausea (13.5% versus 2.6%), decreased appetite (10.8% versus 0%), insomnia (10.8% versus 0%), orthostatic hypotension (10.8% versus 0%), constipation (8.1% versus 0%), falls (8.1% versus 5.3%), and visual hallucinations (8.1% versus 5.3%). Adverse events led to treatment discontinuation in 19% versus 8%, respectively.
Conclusion
ADS‐5102 274 mg is an oral pharmacotherapy demonstrating a significant decrease in levodopa‐induced dyskinesia and improving OFF time. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. |
| doi_str_mv | 10.1002/mds.27131 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5763269</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1977114124</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5091-e46bd7e34bb6c3aac1e31aa0b42bb517ab0c99e445090f90642bf275428c930e3</originalsourceid><addsrcrecordid>eNp1kU1u1DAYhiMEokNhwQWQJRbMSKT1T5yfDdKoM0ClQSAG1pZjfwEXx07tpDCsOAJ34GacBLdTKkBiZdnv40ef_WbZQ4KPCMb0uNfxiFaEkVvZjHBG8pry6nY2w3XNc0ZqfpDdi_EMY0I4Ke9mB7SuGeMlnWU_3kqnfW--gn6KBisVtP7nt-_KuzF4a0GjMRhpke_QcrVNCSeYornspRulNg4WCL6M4DToFAawICMgJYc4WYio8wFZuPDaDzLlxulJJafexU_pbjQSGYfeyJB20bsnEWkTrwzz9XK7RpvTFWKL-9mdTtoID67Xw-z98_W7k5f55vWL05PlJlccNySHomx1Baxo21IxKRUBRqTEbUHblpNKtlg1DRRFonHX4DKdd7TiBa1VwzCww-zZ3jtMbQ9aQfoDacUQTC_DTnhpxN-JMx_FB38heFUyWjZJML8WBH8-QRxFb6ICa6UDP0VBGkZJWVF8iT7-Bz3zU3DpeYmqKkIKQotELfaUCj7GAN3NMASLy-pFql5cVZ_YR39Of0P-7joBx3vgs7Gw-79JvFpt98pfsqa9Eg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1977114124</pqid></control><display><type>article</type><title>Randomized, placebo‐controlled trial of ADS‐5102 (amantadine) extended‐release capsules for levodopa‐induced dyskinesia in Parkinson's disease (EASE LID 3)</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Oertel, Wolfgang ; Eggert, Karla ; Pahwa, Rajesh ; Tanner, Caroline M. ; Hauser, Robert A. ; Trenkwalder, Claudia ; Ehret, Reinhard ; Azulay, Jean Philippe ; Isaacson, Stuart ; Felt, Larissa ; Stempien, Mary Jean</creator><creatorcontrib>Oertel, Wolfgang ; Eggert, Karla ; Pahwa, Rajesh ; Tanner, Caroline M. ; Hauser, Robert A. ; Trenkwalder, Claudia ; Ehret, Reinhard ; Azulay, Jean Philippe ; Isaacson, Stuart ; Felt, Larissa ; Stempien, Mary Jean</creatorcontrib><description>ABSTRACT
Background
The treatment of levodopa‐induced dyskinesia in Parkinson's disease (PD) is an unmet need with no approved drug therapy.
Objective
The purpose of this study was to investigate the efficacy and safety of 274 mg ADS‐5102 (amantadine) extended‐release capsules (equivalent to 340‐mg amantadine HCl) for levodopa‐induced dyskinesia in a randomized controlled trial.
Methods
PD patients with ≥1 hour of troublesome dyskinesia and at least mild functional impact were randomized to placebo or ADS‐5102 once daily at bedtime for 13 weeks. The primary efficacy analysis was based on change from baseline to week 12 on the Unified Dyskinesia Rating Scale total score in the modified intent‐to‐treat population. OFF time was a key secondary measure.
Results
At week 12, least‐squares mean change in the Unified Dyskinesia Rating Scale was −20.7 (standard error 2.2) for ADS‐5102 (n = 37) and –6.3 (standard error 2.1) for placebo (n = 38; treatment difference −14.4, 95% confidence interval −20.4 to −8.3, P < .0001), indicating improvement in levodopa‐induced dyskinesia. OFF time decreased 0.5 hours (standard error 0.3) for ADS‐5102 from a baseline mean of 2.6 hours and increased 0.6 hours (standard error 0.3) for placebo from a baseline mean of 2.0 hours (treatment difference −1.1 hours, 95% confidence interval −2.0 to −0.2, P = .0199). The most common adverse events (ADS‐5102 versus placebo) included dry mouth (13.5% versus 2.6%), nausea (13.5% versus 2.6%), decreased appetite (10.8% versus 0%), insomnia (10.8% versus 0%), orthostatic hypotension (10.8% versus 0%), constipation (8.1% versus 0%), falls (8.1% versus 5.3%), and visual hallucinations (8.1% versus 5.3%). Adverse events led to treatment discontinuation in 19% versus 8%, respectively.
Conclusion
ADS‐5102 274 mg is an oral pharmacotherapy demonstrating a significant decrease in levodopa‐induced dyskinesia and improving OFF time. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. 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.27131</identifier><identifier>PMID: 28833562</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Amantadine ; Amantadine - therapeutic use ; Antiparkinson Agents - adverse effects ; Antiparkinson Agents - therapeutic use ; Appetite loss ; Confidence intervals ; Constipation ; Delayed-Action Preparations - therapeutic use ; Double-Blind Method ; Drug therapy ; Dyskinesia ; Dyskinesia, Drug-Induced - drug therapy ; Dyskinesia, Drug-Induced - etiology ; Female ; Hallucinations ; Humans ; Hypotension ; Levodopa ; Levodopa - adverse effects ; levodopa‐induced dyskinesia ; Male ; Middle Aged ; Movement disorders ; Nausea ; Neurodegenerative diseases ; Parkinson Disease - drug therapy ; Parkinson's disease ; randomized controlled trial ; Retrospective Studies ; Severity of Illness Index ; Sleep disorders ; Time Factors ; Treatment Outcome ; Unified Dyskinesia Rating Scale</subject><ispartof>Movement disorders, 2017-12, Vol.32 (12), p.1701-1709</ispartof><rights>2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</rights><rights>2017 International Parkinson and Movement Disorder Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5091-e46bd7e34bb6c3aac1e31aa0b42bb517ab0c99e445090f90642bf275428c930e3</citedby><cites>FETCH-LOGICAL-c5091-e46bd7e34bb6c3aac1e31aa0b42bb517ab0c99e445090f90642bf275428c930e3</cites></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.27131$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fmds.27131$$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/28833562$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Oertel, Wolfgang</creatorcontrib><creatorcontrib>Eggert, Karla</creatorcontrib><creatorcontrib>Pahwa, Rajesh</creatorcontrib><creatorcontrib>Tanner, Caroline M.</creatorcontrib><creatorcontrib>Hauser, Robert A.</creatorcontrib><creatorcontrib>Trenkwalder, Claudia</creatorcontrib><creatorcontrib>Ehret, Reinhard</creatorcontrib><creatorcontrib>Azulay, Jean Philippe</creatorcontrib><creatorcontrib>Isaacson, Stuart</creatorcontrib><creatorcontrib>Felt, Larissa</creatorcontrib><creatorcontrib>Stempien, Mary Jean</creatorcontrib><title>Randomized, placebo‐controlled trial of ADS‐5102 (amantadine) extended‐release capsules for levodopa‐induced dyskinesia in Parkinson's disease (EASE LID 3)</title><title>Movement disorders</title><addtitle>Mov Disord</addtitle><description>ABSTRACT
Background
The treatment of levodopa‐induced dyskinesia in Parkinson's disease (PD) is an unmet need with no approved drug therapy.
Objective
The purpose of this study was to investigate the efficacy and safety of 274 mg ADS‐5102 (amantadine) extended‐release capsules (equivalent to 340‐mg amantadine HCl) for levodopa‐induced dyskinesia in a randomized controlled trial.
Methods
PD patients with ≥1 hour of troublesome dyskinesia and at least mild functional impact were randomized to placebo or ADS‐5102 once daily at bedtime for 13 weeks. The primary efficacy analysis was based on change from baseline to week 12 on the Unified Dyskinesia Rating Scale total score in the modified intent‐to‐treat population. OFF time was a key secondary measure.
Results
At week 12, least‐squares mean change in the Unified Dyskinesia Rating Scale was −20.7 (standard error 2.2) for ADS‐5102 (n = 37) and –6.3 (standard error 2.1) for placebo (n = 38; treatment difference −14.4, 95% confidence interval −20.4 to −8.3, P < .0001), indicating improvement in levodopa‐induced dyskinesia. OFF time decreased 0.5 hours (standard error 0.3) for ADS‐5102 from a baseline mean of 2.6 hours and increased 0.6 hours (standard error 0.3) for placebo from a baseline mean of 2.0 hours (treatment difference −1.1 hours, 95% confidence interval −2.0 to −0.2, P = .0199). The most common adverse events (ADS‐5102 versus placebo) included dry mouth (13.5% versus 2.6%), nausea (13.5% versus 2.6%), decreased appetite (10.8% versus 0%), insomnia (10.8% versus 0%), orthostatic hypotension (10.8% versus 0%), constipation (8.1% versus 0%), falls (8.1% versus 5.3%), and visual hallucinations (8.1% versus 5.3%). Adverse events led to treatment discontinuation in 19% versus 8%, respectively.
Conclusion
ADS‐5102 274 mg is an oral pharmacotherapy demonstrating a significant decrease in levodopa‐induced dyskinesia and improving OFF time. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amantadine</subject><subject>Amantadine - therapeutic use</subject><subject>Antiparkinson Agents - adverse effects</subject><subject>Antiparkinson Agents - therapeutic use</subject><subject>Appetite loss</subject><subject>Confidence intervals</subject><subject>Constipation</subject><subject>Delayed-Action Preparations - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Dyskinesia</subject><subject>Dyskinesia, Drug-Induced - drug therapy</subject><subject>Dyskinesia, Drug-Induced - etiology</subject><subject>Female</subject><subject>Hallucinations</subject><subject>Humans</subject><subject>Hypotension</subject><subject>Levodopa</subject><subject>Levodopa - adverse effects</subject><subject>levodopa‐induced dyskinesia</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Movement disorders</subject><subject>Nausea</subject><subject>Neurodegenerative diseases</subject><subject>Parkinson Disease - drug therapy</subject><subject>Parkinson's disease</subject><subject>randomized controlled trial</subject><subject>Retrospective Studies</subject><subject>Severity of Illness Index</subject><subject>Sleep disorders</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Unified Dyskinesia Rating Scale</subject><issn>0885-3185</issn><issn>1531-8257</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kU1u1DAYhiMEokNhwQWQJRbMSKT1T5yfDdKoM0ClQSAG1pZjfwEXx07tpDCsOAJ34GacBLdTKkBiZdnv40ef_WbZQ4KPCMb0uNfxiFaEkVvZjHBG8pry6nY2w3XNc0ZqfpDdi_EMY0I4Ke9mB7SuGeMlnWU_3kqnfW--gn6KBisVtP7nt-_KuzF4a0GjMRhpke_QcrVNCSeYornspRulNg4WCL6M4DToFAawICMgJYc4WYio8wFZuPDaDzLlxulJJafexU_pbjQSGYfeyJB20bsnEWkTrwzz9XK7RpvTFWKL-9mdTtoID67Xw-z98_W7k5f55vWL05PlJlccNySHomx1Baxo21IxKRUBRqTEbUHblpNKtlg1DRRFonHX4DKdd7TiBa1VwzCww-zZ3jtMbQ9aQfoDacUQTC_DTnhpxN-JMx_FB38heFUyWjZJML8WBH8-QRxFb6ICa6UDP0VBGkZJWVF8iT7-Bz3zU3DpeYmqKkIKQotELfaUCj7GAN3NMASLy-pFql5cVZ_YR39Of0P-7joBx3vgs7Gw-79JvFpt98pfsqa9Eg</recordid><startdate>201712</startdate><enddate>201712</enddate><creator>Oertel, Wolfgang</creator><creator>Eggert, Karla</creator><creator>Pahwa, Rajesh</creator><creator>Tanner, Caroline M.</creator><creator>Hauser, Robert A.</creator><creator>Trenkwalder, Claudia</creator><creator>Ehret, Reinhard</creator><creator>Azulay, Jean Philippe</creator><creator>Isaacson, Stuart</creator><creator>Felt, Larissa</creator><creator>Stempien, Mary Jean</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons 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></search><sort><creationdate>201712</creationdate><title>Randomized, placebo‐controlled trial of ADS‐5102 (amantadine) extended‐release capsules for levodopa‐induced dyskinesia in Parkinson's disease (EASE LID 3)</title><author>Oertel, Wolfgang ; Eggert, Karla ; Pahwa, Rajesh ; Tanner, Caroline M. ; Hauser, Robert A. ; Trenkwalder, Claudia ; Ehret, Reinhard ; Azulay, Jean Philippe ; Isaacson, Stuart ; Felt, Larissa ; Stempien, Mary Jean</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5091-e46bd7e34bb6c3aac1e31aa0b42bb517ab0c99e445090f90642bf275428c930e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amantadine</topic><topic>Amantadine - therapeutic use</topic><topic>Antiparkinson Agents - adverse effects</topic><topic>Antiparkinson Agents - therapeutic use</topic><topic>Appetite loss</topic><topic>Confidence intervals</topic><topic>Constipation</topic><topic>Delayed-Action Preparations - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Dyskinesia</topic><topic>Dyskinesia, Drug-Induced - drug therapy</topic><topic>Dyskinesia, Drug-Induced - etiology</topic><topic>Female</topic><topic>Hallucinations</topic><topic>Humans</topic><topic>Hypotension</topic><topic>Levodopa</topic><topic>Levodopa - adverse effects</topic><topic>levodopa‐induced dyskinesia</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Movement disorders</topic><topic>Nausea</topic><topic>Neurodegenerative diseases</topic><topic>Parkinson Disease - drug therapy</topic><topic>Parkinson's disease</topic><topic>randomized controlled trial</topic><topic>Retrospective Studies</topic><topic>Severity of Illness Index</topic><topic>Sleep disorders</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Unified Dyskinesia Rating Scale</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Oertel, Wolfgang</creatorcontrib><creatorcontrib>Eggert, Karla</creatorcontrib><creatorcontrib>Pahwa, Rajesh</creatorcontrib><creatorcontrib>Tanner, Caroline M.</creatorcontrib><creatorcontrib>Hauser, Robert A.</creatorcontrib><creatorcontrib>Trenkwalder, Claudia</creatorcontrib><creatorcontrib>Ehret, Reinhard</creatorcontrib><creatorcontrib>Azulay, Jean Philippe</creatorcontrib><creatorcontrib>Isaacson, Stuart</creatorcontrib><creatorcontrib>Felt, Larissa</creatorcontrib><creatorcontrib>Stempien, Mary Jean</creatorcontrib><collection>Wiley Online Library Open Access</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>Oertel, Wolfgang</au><au>Eggert, Karla</au><au>Pahwa, Rajesh</au><au>Tanner, Caroline M.</au><au>Hauser, Robert A.</au><au>Trenkwalder, Claudia</au><au>Ehret, Reinhard</au><au>Azulay, Jean Philippe</au><au>Isaacson, Stuart</au><au>Felt, Larissa</au><au>Stempien, Mary Jean</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized, placebo‐controlled trial of ADS‐5102 (amantadine) extended‐release capsules for levodopa‐induced dyskinesia in Parkinson's disease (EASE LID 3)</atitle><jtitle>Movement disorders</jtitle><addtitle>Mov Disord</addtitle><date>2017-12</date><risdate>2017</risdate><volume>32</volume><issue>12</issue><spage>1701</spage><epage>1709</epage><pages>1701-1709</pages><issn>0885-3185</issn><eissn>1531-8257</eissn><abstract>ABSTRACT
Background
The treatment of levodopa‐induced dyskinesia in Parkinson's disease (PD) is an unmet need with no approved drug therapy.
Objective
The purpose of this study was to investigate the efficacy and safety of 274 mg ADS‐5102 (amantadine) extended‐release capsules (equivalent to 340‐mg amantadine HCl) for levodopa‐induced dyskinesia in a randomized controlled trial.
Methods
PD patients with ≥1 hour of troublesome dyskinesia and at least mild functional impact were randomized to placebo or ADS‐5102 once daily at bedtime for 13 weeks. The primary efficacy analysis was based on change from baseline to week 12 on the Unified Dyskinesia Rating Scale total score in the modified intent‐to‐treat population. OFF time was a key secondary measure.
Results
At week 12, least‐squares mean change in the Unified Dyskinesia Rating Scale was −20.7 (standard error 2.2) for ADS‐5102 (n = 37) and –6.3 (standard error 2.1) for placebo (n = 38; treatment difference −14.4, 95% confidence interval −20.4 to −8.3, P < .0001), indicating improvement in levodopa‐induced dyskinesia. OFF time decreased 0.5 hours (standard error 0.3) for ADS‐5102 from a baseline mean of 2.6 hours and increased 0.6 hours (standard error 0.3) for placebo from a baseline mean of 2.0 hours (treatment difference −1.1 hours, 95% confidence interval −2.0 to −0.2, P = .0199). The most common adverse events (ADS‐5102 versus placebo) included dry mouth (13.5% versus 2.6%), nausea (13.5% versus 2.6%), decreased appetite (10.8% versus 0%), insomnia (10.8% versus 0%), orthostatic hypotension (10.8% versus 0%), constipation (8.1% versus 0%), falls (8.1% versus 5.3%), and visual hallucinations (8.1% versus 5.3%). Adverse events led to treatment discontinuation in 19% versus 8%, respectively.
Conclusion
ADS‐5102 274 mg is an oral pharmacotherapy demonstrating a significant decrease in levodopa‐induced dyskinesia and improving OFF time. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>28833562</pmid><doi>10.1002/mds.27131</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0885-3185 |
| ispartof | Movement disorders, 2017-12, Vol.32 (12), p.1701-1709 |
| issn | 0885-3185 1531-8257 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5763269 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult Aged Aged, 80 and over Amantadine Amantadine - therapeutic use Antiparkinson Agents - adverse effects Antiparkinson Agents - therapeutic use Appetite loss Confidence intervals Constipation Delayed-Action Preparations - therapeutic use Double-Blind Method Drug therapy Dyskinesia Dyskinesia, Drug-Induced - drug therapy Dyskinesia, Drug-Induced - etiology Female Hallucinations Humans Hypotension Levodopa Levodopa - adverse effects levodopa‐induced dyskinesia Male Middle Aged Movement disorders Nausea Neurodegenerative diseases Parkinson Disease - drug therapy Parkinson's disease randomized controlled trial Retrospective Studies Severity of Illness Index Sleep disorders Time Factors Treatment Outcome Unified Dyskinesia Rating Scale |
| title | Randomized, placebo‐controlled trial of ADS‐5102 (amantadine) extended‐release capsules for levodopa‐induced dyskinesia in Parkinson's disease (EASE LID 3) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-25T15%3A37%3A43IST&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=Randomized,%20placebo%E2%80%90controlled%20trial%20of%20ADS%E2%80%905102%20(amantadine)%20extended%E2%80%90release%20capsules%20for%20levodopa%E2%80%90induced%20dyskinesia%20in%20Parkinson's%20disease%20(EASE%20LID%203)&rft.jtitle=Movement%20disorders&rft.au=Oertel,%20Wolfgang&rft.date=2017-12&rft.volume=32&rft.issue=12&rft.spage=1701&rft.epage=1709&rft.pages=1701-1709&rft.issn=0885-3185&rft.eissn=1531-8257&rft_id=info:doi/10.1002/mds.27131&rft_dat=%3Cproquest_pubme%3E1977114124%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=1977114124&rft_id=info:pmid/28833562&rfr_iscdi=true |