Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease
Identifieur interne : 001724 ( Main/Exploration ); précédent : 001723; suivant : 001725Crossover 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 ] ; 2011-10.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Advanced stage, Aged, Aged, 80 and over, Analysis of Variance, Antiparkinson Agents (blood), Antiparkinson Agents (therapeutic use), Carbidopa (pharmacokinetics), Carbidopa (therapeutic use), Comparative study, Cross-Over Studies, Delayed-Action Preparations (therapeutic use), Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Combinations, Female, Fluctuations, Formulation, Humans, IPX066, Levodopa, Levodopa (blood), Levodopa (pharmacokinetics), Levodopa (therapeutic use), Male, Middle Aged, Movement (drug effects), Nervous system diseases, Parkinson Disease (blood), Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Pharmacokinetics, Release, Time Factors, extended‐release levodopa, motor effects, motor fluctuations, pharmacokinetics.
- 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 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. © 2011 Movement Disorder Society
Url:
DOI: 10.1002/mds.23861
Affiliations:
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<term>Aged</term>
<term>Aged, 80 and over</term>
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<term>Antiparkinson Agents (blood)</term>
<term>Antiparkinson Agents (therapeutic use)</term>
<term>Carbidopa (pharmacokinetics)</term>
<term>Carbidopa (therapeutic use)</term>
<term>Comparative study</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>Fluctuations</term>
<term>Formulation</term>
<term>Humans</term>
<term>IPX066</term>
<term>Levodopa</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>Nervous system diseases</term>
<term>Parkinson Disease (blood)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson disease</term>
<term>Parkinson's disease</term>
<term>Pharmacokinetics</term>
<term>Release</term>
<term>Time Factors</term>
<term>extended‐release levodopa</term>
<term>motor effects</term>
<term>motor fluctuations</term>
<term>pharmacokinetics</term>
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<term>Delayed-Action Preparations</term>
<term>Levodopa</term>
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<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 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. © 2011 Movement Disorder Society</div>
</front>
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<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 Ing" sort="Yao, Hsuan Ing" uniqKey="Yao H" first="Hsuan-Ming" last="Yao">Hsuan-Ming Yao</name>
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