Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial.
Identifieur interne : 000620 ( PubMed/Checkpoint ); précédent : 000619; suivant : 000621Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial.
Auteurs : Robert A. Hauser [États-Unis] ; C Warren Olanow [États-Unis] ; Karl D. Kieburtz [États-Unis] ; Emmanuelle Pourcher [Canada] ; Any Docu-Axelerad [Roumanie] ; Mark Lew [États-Unis] ; Olexandr Kozyolkin [Ukraine] ; Ann Neale [États-Unis] ; Chris Resburg [États-Unis] ; Uwe Meya [États-Unis] ; Christopher Kenney [États-Unis] ; Stephen Bandak [États-Unis]Source :
- The Lancet. Neurology [ 1474-4465 ] ; 2014.
English descriptors
- KwdEn :
- Adenosine A2 Receptor Antagonists (adverse effects), Aged, Antiparkinson Agents (adverse effects), Benzothiazoles (adverse effects), Cross-Over Studies, Double-Blind Method, Dyskinesia, Drug-Induced (diagnosis), Dyskinesia, Drug-Induced (epidemiology), Female, Humans, Internationality, Levodopa (adverse effects), Male, Middle Aged, Parkinson Disease (diagnosis), Parkinson Disease (drug therapy), Parkinson Disease (epidemiology).
- MESH :
- chemical , adverse effects : Adenosine A2 Receptor Antagonists, Antiparkinson Agents, Benzothiazoles, Levodopa.
- diagnosis : Dyskinesia, Drug-Induced, Parkinson Disease.
- drug therapy : Parkinson Disease.
- epidemiology : Dyskinesia, Drug-Induced, Parkinson Disease.
- Aged, Cross-Over Studies, Double-Blind Method, Female, Humans, Internationality, Male, Middle Aged.
Abstract
Many patients with Parkinson's disease have motor fluctuations despite treatment with available drugs. Tozadenant (SYN115) is an oral, selective adenosine A2A receptor antagonist that improves motor function in animal models of Parkinson's disease. We aimed to assess the safety and efficacy of tozadenant as an adjunct to levodopa in patients with Parkinson's disease who have motor fluctuations on levodopa.
DOI: 10.1016/S1474-4422(14)70148-6
PubMed: 25008546
Affiliations:
- Canada, Roumanie, Ukraine, États-Unis
- Californie, Floride, État de New York
- Los Angeles
- Université de Californie du Sud
Links toward previous steps (curation, corpus...)
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pubmed:25008546Le document en format XML
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<term>Benzothiazoles (adverse effects)</term>
<term>Cross-Over Studies</term>
<term>Double-Blind Method</term>
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<front><div type="abstract" xml:lang="en">Many patients with Parkinson's disease have motor fluctuations despite treatment with available drugs. Tozadenant (SYN115) is an oral, selective adenosine A2A receptor antagonist that improves motor function in animal models of Parkinson's disease. We aimed to assess the safety and efficacy of tozadenant as an adjunct to levodopa in patients with Parkinson's disease who have motor fluctuations on levodopa.</div>
</front>
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<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25008546</PMID>
<DateCreated><Year>2014</Year>
<Month>07</Month>
<Day>17</Day>
</DateCreated>
<DateCompleted><Year>2014</Year>
<Month>09</Month>
<Day>15</Day>
</DateCompleted>
<DateRevised><Year>2016</Year>
<Month>07</Month>
<Day>01</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-4465</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>13</Volume>
<Issue>8</Issue>
<PubDate><Year>2014</Year>
<Month>Aug</Month>
</PubDate>
</JournalIssue>
<Title>The Lancet. Neurology</Title>
<ISOAbbreviation>Lancet Neurol</ISOAbbreviation>
</Journal>
<ArticleTitle>Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial.</ArticleTitle>
<Pagination><MedlinePgn>767-76</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/S1474-4422(14)70148-6</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S1474-4422(14)70148-6</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Many patients with Parkinson's disease have motor fluctuations despite treatment with available drugs. Tozadenant (SYN115) is an oral, selective adenosine A2A receptor antagonist that improves motor function in animal models of Parkinson's disease. We aimed to assess the safety and efficacy of tozadenant as an adjunct to levodopa in patients with Parkinson's disease who have motor fluctuations on levodopa.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">We did an international, multicentre, phase 2b, randomised, double-blind, placebo-controlled, parallel-group, dose-finding clinical trial of tozadenant in levodopa-treated patients with Parkinson's disease who had motor fluctuations (at least 2·5 h off-time per day). Eligible patients were randomly assigned via a computer-generated randomisation schedule to receive tozadenant 60, 120, 180, or 240 mg or matching placebo twice daily for 12 weeks. All study management, site personnel, and patients were masked to treatment assignment. The primary outcome was change from baseline to week 12 in hours per day spent in the off-state (assessed from Parkinson's disease diaries completed by patients). This study is registered at ClinicalTrials.gov, number NCT01283594.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">Of 420 randomised patients (mean age 63·3 [SD 8·3] years; mean duration of Parkinson's disease 8·7 [4·7] years), 403 provided post-baseline diary data and 337 completed study treatment. Compared with placebo, mean daily off-time was significantly reduced in the combined tozadenant 120 mg twice-daily and 180 mg twice-daily group (-1·1 h, 95% CI -1·8 to -0·5; p=0·0006), the tozadenant 120 mg twice-daily group (-1·1 h, -1·8 to -0·4; p=0.0039), and the tozadenant 180 mg twice-daily group (-1·2 h, -1·9 to -0·4; p=0·0039). The most common adverse events in these groups were dyskinesia (seven [8%] of 84 patients in the placebo group, 13 [16%] of 82 in the 120 mg twice-daily group, and 17 [20%] of 85 in the 180 mg twice-daily group), nausea (three [4%], 9 [11%], and ten [12%]), and dizziness (one [1%], four [5%], and 11 [13%]). Tozadenant 60 mg twice daily was not associated with a significant reduction in off-time, and tozadenant 240 mg twice daily was associated with an increased rate of discontinuation because of adverse events (17 [20%] of 84 patients).</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Tozadenant at 120 or 180 mg twice daily was generally well tolerated and was effective at reducing off-time. Further investigation of tozadenant treatment in phase 3 trials is warranted.</AbstractText>
<AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Biotie Therapies.</AbstractText>
<CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Hauser</LastName>
<ForeName>Robert A</ForeName>
<Initials>RA</Initials>
<AffiliationInfo><Affiliation>University of South Florida Parkinson's Disease and Movement Disorders Center, National Parkinson Foundation Center of Excellence, Tampa, FL, USA. Electronic address: rhauser@health.usf.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Olanow</LastName>
<ForeName>C Warren</ForeName>
<Initials>CW</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, Mount Sinai School of Medicine, New York, NY, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kieburtz</LastName>
<ForeName>Karl D</ForeName>
<Initials>KD</Initials>
<AffiliationInfo><Affiliation>University of Rochester School of Medicine, Rochester, NY, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pourcher</LastName>
<ForeName>Emmanuelle</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Clinique Sainte-Anne Mémoire et Mouvement, Faculty of Medicine, Laval University, Quebec, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Docu-Axelerad</LastName>
<ForeName>Any</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Department of General Medicine, Ovidius University of Constanta, Constanta, Romania.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lew</LastName>
<ForeName>Mark</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kozyolkin</LastName>
<ForeName>Olexandr</ForeName>
<Initials>O</Initials>
<AffiliationInfo><Affiliation>Department of General Neurology, Zaporizhzhya State Medical University, Zaporizhzhya, Ukraine.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Neale</LastName>
<ForeName>Ann</ForeName>
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<Author ValidYN="Y"><LastName>Resburg</LastName>
<ForeName>Chris</ForeName>
<Initials>C</Initials>
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</AffiliationInfo>
</Author>
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<ForeName>Uwe</ForeName>
<Initials>U</Initials>
<AffiliationInfo><Affiliation>Biotie Therapies, South San Francisco, CA, USA.</Affiliation>
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</Author>
<Author ValidYN="Y"><LastName>Kenney</LastName>
<ForeName>Christopher</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Biotie Therapies, South San Francisco, CA, USA.</Affiliation>
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<AffiliationInfo><Affiliation>Biotie Therapies, South San Francisco, CA, USA.</Affiliation>
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<Day>06</Day>
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<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Lancet Neurol</MedlineTA>
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<CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Lancet Neurol. 2014 Aug;13(8):748-9</RefSource>
<PMID Version="1">25008550</PMID>
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<PubMedPubDate PubStatus="medline"><Year>2014</Year>
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<li>Ukraine</li>
<li>États-Unis</li>
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<region><li>Californie</li>
<li>Floride</li>
<li>État de New York</li>
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<settlement><li>Los Angeles</li>
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