MovDisordV3, PascalFrancis, Corpus, bibRecord, 000371

Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease

Identifieur interne : 000371 ( PascalFrancis/Corpus ); précédent : 000370; suivant : 000372

Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease

Auteurs : Robert A. Hauser ; Aaron L. Ellenbogen ; Leo Verhagen Metman ; Ann Hsu ; Martin J. O'Connell ; Nishit B. Modi ; Hsuan-Ming Yao ; Sherron H. Kell ; Suneel K. Gupta

Source :

Movement disorders [ 0885-3185 ] ; 2011.

RBID : Pascal:11-0481763

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Etude comparative, Lévodopa, Formulation, Stade avancé, Libération, Pharmacocinétique, Fluctuation.

English descriptors

KwdEn :
- Advanced stage, Comparative study, Fluctuations, Formulation, Levodopa, Nervous system diseases, Parkinson disease, Pharmacokinetics, Release.

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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C01	`01`		`ENG`	@0 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.
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Format Inist (serveur)

NO :	PASCAL 11-0481763 INIST
ET :	Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease
AU :	HAUSER (Robert A.); ELLENBOGEN (Aaron L.); METMAN (Leo Verhagen); HSU (Ann); O'CONNELL (Martin J.); MODI (Nishit B.); YAO (Hsuan-Ming); KELL (Sherron H.); GUPTA (Suneel K.)
AF :	Parkinson's Disease and Movement Disorders Center, University of South Florida/Tampa, Florida/Etats-Unis (1 aut.); Michigan Institute for Neurological Disorders and Quest Research Institute/Farmington Hills, Michigan/Etats-Unis (2 aut.); Rush University Medical Center/Chicago, Illinois/Etats-Unis (3 aut.); Impax Pharmaceuticals/Hayward, California/Etats-Unis (4 aut., 5 aut., 6 aut., 7 aut., 8 aut., 9 aut.)
DT :	Publication en série; Niveau analytique
SO :	Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2011; Vol. 26; No. 12; Pp. 2246-2252; Bibl. 20 ref.
LA :	Anglais
EA :	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.
CC :	002B17; 002B17G
FD :	Maladie de Parkinson; Pathologie du système nerveux; Etude comparative; Lévodopa; Formulation; Stade avancé; Libération; Pharmacocinétique; Fluctuation
FG :	Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central
ED :	Parkinson disease; Nervous system diseases; Comparative study; Levodopa; Formulation; Advanced stage; Release; Pharmacokinetics; Fluctuations
EG :	Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD :	Parkinson enfermedad; Sistema nervioso patología; Estudio comparativo; Levodopa; Formulación; Estadio avanzado; Liberación; Farmacocinética; Fluctuación
LO :	INIST-20953.354000505557630170
ID :	11-0481763

Links to Exploration step

Pascal:11-0481763

Le document en format XML

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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 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>
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<fA08 i1="01" i2="1" l="ENG"><s1>Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease</s1>
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<fA11 i1="01" i2="1"><s1>HAUSER (Robert A.)</s1>
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<fA11 i1="02" i2="1"><s1>ELLENBOGEN (Aaron L.)</s1>
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<sZ>6 aut.</sZ>
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 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.</s0>
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<ET>Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease</ET>
<AU>HAUSER (Robert A.); ELLENBOGEN (Aaron L.); METMAN (Leo Verhagen); HSU (Ann); O'CONNELL (Martin J.); MODI (Nishit B.); YAO (Hsuan-Ming); KELL (Sherron H.); GUPTA (Suneel K.)</AU>
<AF>Parkinson's Disease and Movement Disorders Center, University of South Florida/Tampa, Florida/Etats-Unis (1 aut.); Michigan Institute for Neurological Disorders and Quest Research Institute/Farmington Hills, Michigan/Etats-Unis (2 aut.); Rush University Medical Center/Chicago, Illinois/Etats-Unis (3 aut.); Impax Pharmaceuticals/Hayward, California/Etats-Unis (4 aut., 5 aut., 6 aut., 7 aut., 8 aut., 9 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2011; Vol. 26; No. 12; Pp. 2246-2252; Bibl. 20 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B17; 002B17G</CC>
<FD>Maladie de Parkinson; Pathologie du   système nerveux; Etude comparative; Lévodopa; Formulation; Stade avancé; Libération; Pharmacocinétique; Fluctuation</FD>
<FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du   système nerveux central</FG>
<ED>Parkinson disease; Nervous system diseases; Comparative study; Levodopa; Formulation; Advanced stage; Release; Pharmacokinetics; Fluctuations</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease

Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease

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