Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease.
Identifieur interne : 003348 ( Ncbi/Checkpoint ); précédent : 003347; suivant : 003349Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease.
Auteurs : Robert A. Hauser [États-Unis] ; Aaron L. Ellenbogen ; Leo Verhagen Metman ; Ann Hsu ; Martin J. O'Connell ; Nishit B. Modi ; Hsuan-Ming Yao ; Sherron H. Kell ; Suneel K. GuptaSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2011.
English descriptors
- KwdEn :
- Aged, Aged, 80 and over, Analysis of Variance, Antiparkinson Agents (blood), Antiparkinson Agents (therapeutic use), Carbidopa (pharmacokinetics), Carbidopa (therapeutic use), Cross-Over Studies, Delayed-Action Preparations (therapeutic use), Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Combinations, Female, Humans, Levodopa (blood), Levodopa (pharmacokinetics), Levodopa (therapeutic use), Male, Middle Aged, Movement (drug effects), Parkinson Disease (blood), Parkinson Disease (drug therapy), Time Factors.
- MESH :
- chemical , blood : Antiparkinson Agents, Levodopa.
- chemical , pharmacokinetics : Carbidopa, Levodopa.
- chemical , therapeutic use : Antiparkinson Agents, Carbidopa, Delayed-Action Preparations, Levodopa.
- blood : Parkinson Disease.
- drug effects : Movement.
- drug therapy : Parkinson Disease.
- Aged, Aged, 80 and over, Analysis of Variance, Cross-Over Studies, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Combinations, Female, Humans, Male, Middle Aged, Time Factors.
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 C(max) 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.
DOI: 10.1002/mds.23861
PubMed: 21755537
Affiliations:
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Ellenbogen</name></author><author><name sortKey="Metman, Leo Verhagen" sort="Metman, Leo Verhagen" uniqKey="Metman L" first="Leo Verhagen" last="Metman">Leo Verhagen Metman</name></author><author><name sortKey="Hsu, Ann" sort="Hsu, Ann" uniqKey="Hsu A" first="Ann" last="Hsu">Ann Hsu</name></author><author><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></author><author><name sortKey="Modi, Nishit B" sort="Modi, Nishit B" uniqKey="Modi N" first="Nishit B" last="Modi">Nishit B. Modi</name></author><author><name sortKey="Yao, Hsuan Ming" sort="Yao, Hsuan Ming" uniqKey="Yao H" first="Hsuan-Ming" last="Yao">Hsuan-Ming Yao</name></author><author><name sortKey="Kell, Sherron H" sort="Kell, Sherron H" uniqKey="Kell S" first="Sherron H" last="Kell">Sherron H. Kell</name></author><author><name sortKey="Gupta, Suneel K" sort="Gupta, Suneel K" uniqKey="Gupta S" first="Suneel K" last="Gupta">Suneel K. Gupta</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Analysis of Variance</term><term>Antiparkinson Agents (blood)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Carbidopa (pharmacokinetics)</term><term>Carbidopa (therapeutic use)</term><term>Cross-Over Studies</term><term>Delayed-Action Preparations (therapeutic use)</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Levodopa (blood)</term><term>Levodopa (pharmacokinetics)</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Movement (drug effects)</term><term>Parkinson Disease (blood)</term><term>Parkinson Disease (drug therapy)</term><term>Time Factors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antiparkinson Agents</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Carbidopa</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Delayed-Action Preparations</term><term>Levodopa</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Movement</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Analysis of Variance</term><term>Cross-Over Studies</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Time Factors</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(max) 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>Floride</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><noCountry><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></noCountry><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. 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