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Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease.
Mov Disord. 2011 Oct; 26(12):2246-52.MD

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.

Authors+Show Affiliations

Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21755537

Citation

Hauser, Robert A., et al. "Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 26, no. 12, 2011, pp. 2246-52.
Hauser RA, Ellenbogen AL, Metman LV, et al. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov Disord. 2011;26(12):2246-52.
Hauser, R. A., Ellenbogen, A. L., Metman, L. V., Hsu, A., O'Connell, M. J., Modi, N. B., Yao, H. M., Kell, S. H., & Gupta, S. K. (2011). Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Movement Disorders : Official Journal of the Movement Disorder Society, 26(12), 2246-52. https://doi.org/10.1002/mds.23861
Hauser RA, et al. Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease. Mov Disord. 2011;26(12):2246-52. PubMed PMID: 21755537.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. AU - Hauser,Robert A, AU - Ellenbogen,Aaron L, AU - Metman,Leo Verhagen, AU - Hsu,Ann, AU - O'Connell,Martin J, AU - Modi,Nishit B, AU - Yao,Hsuan-Ming, AU - Kell,Sherron H, AU - Gupta,Suneel K, Y1 - 2011/07/13/ PY - 2011/01/18/received PY - 2011/05/24/revised PY - 2011/06/08/accepted PY - 2011/7/15/entrez PY - 2011/7/15/pubmed PY - 2012/3/6/medline SP - 2246 EP - 52 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 26 IS - 12 N2 - 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. SN - 1531-8257 UR - https://www.unboundmedicine.com/medline/citation/21755537/Crossover_comparison_of_IPX066_and_a_standard_levodopa_formulation_in_advanced_Parkinson's_disease_ L2 - https://doi.org/10.1002/mds.23861 DB - PRIME DP - Unbound Medicine ER -