Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease.
Identifieur interne : 000795 ( PubMed/Curation ); précédent : 000794; suivant : 000796Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease.
Auteurs : Rajesh Pahwa [États-Unis] ; Kelly E. Lyons [États-Unis] ; Robert A. Hauser [États-Unis] ; Stanley Fahn [États-Unis] ; Joseph Jankovic [États-Unis] ; Emmanuelle Pourcher [Canada] ; Ann Hsu [États-Unis] ; Martin O'Connell [États-Unis] ; Sherron Kell [États-Unis] ; Suneel Gupta [États-Unis]Source :
- Parkinsonism & related disorders [ 1873-5126 ] ; 2014.
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Carbidopa (administration & dosage), Carbidopa (adverse effects), Dose-Response Relationship, Drug, Double-Blind Method, Drug Combinations, Female, Humans, Levodopa (administration & dosage), Levodopa (adverse effects), Levodopa (metabolism), Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson Disease (metabolism), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Carbidopa, Levodopa.
- chemical , adverse effects : Antiparkinson Agents, Carbidopa, Levodopa.
- chemical , metabolism : Levodopa.
- drug therapy : Parkinson Disease.
- metabolism : Parkinson Disease.
- Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
IPX066 is an extended release carbidopa/levodopa formulation designed to rapidly attain and maintain therapeutic plasma concentrations for a prolonged duration, allowing dosing intervals of approximately 6 h. The objective was to assess the efficacy, safety, and impact on quality of life of IPX066 in the treatment of levodopa-naive Parkinson's disease (PD) patients.
DOI: 10.1016/j.parkreldis.2013.08.017
PubMed: 24055014
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pubmed:24055014Le document en format XML
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<front><div type="abstract" xml:lang="en">IPX066 is an extended release carbidopa/levodopa formulation designed to rapidly attain and maintain therapeutic plasma concentrations for a prolonged duration, allowing dosing intervals of approximately 6 h. The objective was to assess the efficacy, safety, and impact on quality of life of IPX066 in the treatment of levodopa-naive Parkinson's disease (PD) patients.</div>
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<DateCreated><Year>2014</Year>
<Month>02</Month>
<Day>03</Day>
</DateCreated>
<DateCompleted><Year>2014</Year>
<Month>09</Month>
<Day>24</Day>
</DateCompleted>
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<Month>02</Month>
<Day>03</Day>
</DateRevised>
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<JournalIssue CitedMedium="Internet"><Volume>20</Volume>
<Issue>2</Issue>
<PubDate><Year>2014</Year>
<Month>Feb</Month>
</PubDate>
</JournalIssue>
<Title>Parkinsonism & related disorders</Title>
<ISOAbbreviation>Parkinsonism Relat. Disord.</ISOAbbreviation>
</Journal>
<ArticleTitle>Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease.</ArticleTitle>
<Pagination><MedlinePgn>142-8</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.parkreldis.2013.08.017</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S1353-8020(13)00311-8</ELocationID>
<Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">IPX066 is an extended release carbidopa/levodopa formulation designed to rapidly attain and maintain therapeutic plasma concentrations for a prolonged duration, allowing dosing intervals of approximately 6 h. The objective was to assess the efficacy, safety, and impact on quality of life of IPX066 in the treatment of levodopa-naive Parkinson's disease (PD) patients.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">This was a randomized, double-blind, placebo-controlled, 30-week study of 381 levodopa-naïve patients assigned to placebo or IPX066 containing 145, 245 or 390 mg of levodopa administered three times daily (TID). The primary efficacy measure was change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) activities of daily living (Part II) + motor scores (Part III), at 30 weeks. Secondary outcome measures included UPDRS total and subscores, patient and clinician global impressions (PGI-I, CGI-I), and the Parkinson's Disease Questionnaire (PDQ-39).</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">All IPX066 dosages were superior to placebo throughout the study and at 30 weeks (P < 0.0001). The mean improvement in UPDRS Parts II + III at 30 weeks compared to baseline was 11.7, 12.9, and 14.9 points for the three dosages and 0.6 points for placebo (P < 0.0001, all dosages). PDQ-39 total scores improved with IPX066 (P ≤ 0.034, all dosages). The most commonly reported adverse events with IPX066 included nausea, dizziness, and headache. No unexpected drug-related serious adverse events were reported.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">IPX066 provided significant clinical benefits at the three dosages tested compared to placebo and was well tolerated in levodopa-naive PD patients. Of the dosages tested, IPX066 145 mg TID appeared to provide the best overall balance between efficacy and safety.</AbstractText>
<CopyrightInformation>Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pahwa</LastName>
<ForeName>Rajesh</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: rpahwa@kumc.edu.</Affiliation>
</AffiliationInfo>
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<ForeName>Kelly E</ForeName>
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<AffiliationInfo><Affiliation>University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: kelly.lyons@att.net.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
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</AffiliationInfo>
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<ForeName>Joseph</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Baylor College of Medicine, Houston, TX, USA. Electronic address: josephj@bcm.edu.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Emmanuelle</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Quebec Memory and Motor Skills Disorders Research Clinic, Quebec City, Canada. Electronic address: psa@riq.qc.ca.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Ann</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: annhsu@impaxlabs.com.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
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<Initials>S</Initials>
<AffiliationInfo><Affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: skell@impaxlabs.com.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Gupta</LastName>
<ForeName>Suneel</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Impax Pharmaceuticals, Hayward, CA, USA. Electronic address: sgupta@impaxlabs.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><CollectiveName>APEX-PD Investigators</CollectiveName>
</Author>
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<Day>05</Day>
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<InvestigatorList><Investigator ValidYN="Y"><LastName>Cohen</LastName>
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<ForeName>Aaron</ForeName>
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