Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease
Identifieur interne : 001C39 ( Main/Merge ); précédent : 001C38; suivant : 001C40Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease
Auteurs : Robert A. Hauser [États-Unis] ; Aaron L. Ellenbogen [États-Unis] ; Leo Verhagen Metman [États-Unis] ; Ann Hsu [États-Unis] ; Martin J. O'Connell [États-Unis] ; Nishit B. Modi [États-Unis] ; Hsuan-Ming Yao [États-Unis] ; Sherron H. Kell [États-Unis] ; Suneel K. Gupta [États-Unis]Source :
- Movement disorders [ 0885-3185 ] ; 2011.
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Abstract
The objective of the study was to compare the pharmacokinetics, motor effects, and safety of IPX066, a novel extended-release formulation of carbidopa-levodopa, with an immediate-release carbidopa-levodopa formulation in advanced Parkinson's disease. We performed an open-label crossover study in 27 subjects with advanced Parkinson's disease experiencing motor fluctuations on levodopa therapy. Subjects were randomized 1:1 to 8 days' treatment with either immediate-release carbidopa-levodopa followed by IPX066 or IPX066 followed by immediate-release carbidopa-levodopa. Pharmacokinetic and motor assessments were undertaken on day 1 for 8 hours (following a single dose) and on day 8 for 12 hours (during multiple-dose administration). Following a single dose of IPX066 or immediate-release carbidopa-levodopa, plasma levodopa concentrations increased at a similarly rapid rate and were sustained above 50% of peak concentration for 4 hours with IPX066 versus 1.4 hours with immediate-release carbidopa-levodopa (P <.0001). Multiple-dose data showed IPX066 substantially reduced variability in plasma levodopa concentrations despite a lower dosing frequency (mean, 3.5 vs 5.4 administrations per day). In addition, total levodopa exposure during IPX066 treatment was approximately 87% higher, whereas the increase in levodopa Cmax was approximately 30% compared with immediate-release carbidopa-levodopa. Both products were well tolerated. IPX066 provided more sustained plasma levodopa concentrations than immediate-release carbidopa-levodopa. Larger, longer-term, well-controlled studies should be conducted to provide rigorous assessment of the clinical effects of IPX066.
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Hauser</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Ellenbogen, Aaron L" sort="Ellenbogen, Aaron L" uniqKey="Ellenbogen A" first="Aaron L." last="Ellenbogen">Aaron L. 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O'Connell</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Impax Pharmaceuticals</s1><s2>Hayward, California</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Modi, Nishit B" sort="Modi, Nishit B" uniqKey="Modi N" first="Nishit B." last="Modi">Nishit B. Modi</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Impax Pharmaceuticals</s1><s2>Hayward, California</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Yao, Hsuan Ming" sort="Yao, Hsuan Ming" uniqKey="Yao H" first="Hsuan-Ming" last="Yao">Hsuan-Ming Yao</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Impax Pharmaceuticals</s1><s2>Hayward, California</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Kell, Sherron H" sort="Kell, Sherron H" uniqKey="Kell S" first="Sherron H." last="Kell">Sherron H. Kell</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Impax Pharmaceuticals</s1><s2>Hayward, California</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Gupta, Suneel K" sort="Gupta, Suneel K" uniqKey="Gupta S" first="Suneel K." last="Gupta">Suneel K. Gupta</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Impax Pharmaceuticals</s1><s2>Hayward, California</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Comparative study</term><term>Fluctuations</term><term>Formulation</term><term>Levodopa</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Pharmacokinetics</term><term>Release</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Etude comparative</term><term>Lévodopa</term><term>Formulation</term><term>Stade avancé</term><term>Libération</term><term>Pharmacocinétique</term><term>Fluctuation</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of the study was to compare the pharmacokinetics, motor effects, and safety of IPX066, a novel extended-release formulation of carbidopa-levodopa, with an immediate-release carbidopa-levodopa formulation in advanced Parkinson's disease. We performed an open-label crossover study in 27 subjects with advanced Parkinson's disease experiencing motor fluctuations on levodopa therapy. Subjects were randomized 1:1 to 8 days' treatment with either immediate-release carbidopa-levodopa followed by IPX066 or IPX066 followed by immediate-release carbidopa-levodopa. Pharmacokinetic and motor assessments were undertaken on day 1 for 8 hours (following a single dose) and on day 8 for 12 hours (during multiple-dose administration). Following a single dose of IPX066 or immediate-release carbidopa-levodopa, plasma levodopa concentrations increased at a similarly rapid rate and were sustained above 50% of peak concentration for 4 hours with IPX066 versus 1.4 hours with immediate-release carbidopa-levodopa (P <.0001). Multiple-dose data showed IPX066 substantially reduced variability in plasma levodopa concentrations despite a lower dosing frequency (mean, 3.5 vs 5.4 administrations per day). In addition, total levodopa exposure during IPX066 treatment was approximately 87% higher, whereas the increase in levodopa C<sub>max</sub> was approximately 30% compared with immediate-release carbidopa-levodopa. Both products were well tolerated. IPX066 provided more sustained plasma levodopa concentrations than immediate-release carbidopa-levodopa. Larger, longer-term, well-controlled studies should be conducted to provide rigorous assessment of the clinical effects of IPX066.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Californie</li><li>Floride</li><li>Illinois</li><li>Michigan</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name></region><name sortKey="Ellenbogen, Aaron L" sort="Ellenbogen, Aaron L" uniqKey="Ellenbogen A" first="Aaron L." last="Ellenbogen">Aaron L. Ellenbogen</name><name sortKey="Gupta, Suneel K" sort="Gupta, Suneel K" uniqKey="Gupta S" first="Suneel K." last="Gupta">Suneel K. Gupta</name><name sortKey="Hsu, Ann" sort="Hsu, Ann" uniqKey="Hsu A" first="Ann" last="Hsu">Ann Hsu</name><name sortKey="Kell, Sherron H" sort="Kell, Sherron H" uniqKey="Kell S" first="Sherron H." last="Kell">Sherron H. Kell</name><name sortKey="Metman, Leo Verhagen" sort="Metman, Leo Verhagen" uniqKey="Metman L" first="Leo Verhagen" last="Metman">Leo Verhagen Metman</name><name sortKey="Modi, Nishit B" sort="Modi, Nishit B" uniqKey="Modi N" first="Nishit B." last="Modi">Nishit B. Modi</name><name sortKey="O Connell, Martin J" sort="O Connell, Martin J" uniqKey="O Connell M" first="Martin J." last="O'Connell">Martin J. O'Connell</name><name sortKey="Yao, Hsuan Ming" sort="Yao, Hsuan Ming" uniqKey="Yao H" first="Hsuan-Ming" last="Yao">Hsuan-Ming Yao</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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