Long-term treatment with extended-release carbidopa-levodopa (IPX066) in early and advanced Parkinson's disease: A 9-month open-label extension trial

CNS Drugs

Volumn 29, Issue 4, 2015, Pages 341-350

  Waters, Cheryl H ^a,h   Nausieda, Paul ^b   Dzyak, Lyudmila ^c   Spiegel, Joerg ^d   Rudzinska, Monika ^e   Silver, Dee E ^f   Tsurkalenko, Elena S ^c   Kell, Sherron ^g   Hsu, Ann ^g   Khanna, Sarita ^g   Gupta, Suneel ^g  

^a Department of Medicine   (United States)

^b Wisconsin Institute for Neurologic and Sleep Disorders   (United States)

^c Dnipropetrovsk State Medical Academy   (Ukraine)

^d SAARLAND UNIVERSITY   (Germany)

^e MEDICAL UNIVERSITY OF SILESIA   (Poland)

^f Coastal Neurological Medical Group ^*  (United States)

^g Impax Laboratories Inc   (United States)

^h Columbia University ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIPARKINSON AGENT; CARBIDOPA; CARBIDOPA, LEVODOPA DRUG COMBINATION; DELAYED RELEASE FORMULATION; DRUG COMBINATION; LEVODOPA;

ADMINISTRATION AND DOSAGE; ADULT; ADVERSE EFFECTS; AGED; BLOOD; CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DELAYED RELEASE FORMULATION; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; DRUG COMBINATION; FEMALE; HUMAN; LONG TERM CARE; MALE; METABOLISM; MIDDLE AGED; PARKINSON DISEASE; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SEVERITY OF ILLNESS INDEX; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIPARKINSON AGENTS; CARBIDOPA; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; HUMANS; LEVODOPA; LONG-TERM CARE; MALE; MIDDLE AGED; PARKINSON DISEASE; SEVERITY OF ILLNESS INDEX;

EID: 84937763232     PISSN: 11727047     EISSN: 11791934     Source Type: Journal    
DOI: 10.1007/s40263-015-0242-2     Document Type: Article

References (34)

1. Jankovic J, Stacy M. Medical management of levodopa-associated motor complications in patients with Parkinson's disease. CNS Drugs. 2007;21:677-92.
2. Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease. Neurology. 2009;72(21 Suppl 4):S1-136.
3. Olanow CW, Kieburtz K, Rascol O, et al. Factors predictive of the development of levodopa-induced dyskinesia and wearing-off in Parkinson's disease. Mov Disord. 2013;28:1064-71.
4. Fahn S, Oakes D, Shoulson I, et al. Levodopa and the progression of Parkinson's disease. N Engl J Med. 2004;351:2498-508.
5. deSouza RM, Moro E, Lang AE, Schapira AH. Timing of deep brain stimulation in Parkinson disease: a need for reappraisal? Ann Neurol. 2013;73:565-75.
6. Dodel RC, Berger K, Oertel WH. Health-related quality of life and healthcare utilisation in patients with Parkinson's disease: impact of motor fluctuations and dyskinesias. Pharmacoeconomics. 2001;19:1013-38.
7. Politis M, Wu K, Molloy S, Bain PG, Chaudhuri KR, Piccini P. Parkinson's disease symptoms: the patient's perspective. Mov Disord. 2010;25:1646-51.
8. Olanow CW, Obeso JA, Stocchi F. Continuous dopamine-receptor treatment of Parkinson's disease: scientific rationale and clinical implications. Lancet Neurol. 2006;5:677-87.
9. Sage JI, Trooskin S, Sonsalla PK, Heikkila R, Duvoisin RC. Long-term duodenal infusion of levodopa for motor fluctuations in parkinsonism. Ann Neurol. 1988;24:87-9.
10. Nilsson D, Hansson LE, Johansson K, Nystrom C, Paalzow L, Aquilonius SM. Long-term intraduodenal infusion of a water based levodopa-carbidopa dispersion in very advanced Parkinson's disease. Acta Neurol Scand. 1998;97:175-83.
11. Stocchi F, Vacca L, Ruggieri S, Olanow CW. Intermittent vs continuous levodopa administration in patients with advanced Parkinson disease: a clinical and pharmacokinetic study. Arch Neurol. 2005;62:905-10.
12. Sinemet-CR (carbidopa-levodopa sustained release) tablets [package insert]. Whitehouse Station: Merck & Co., and Princeton: Bristol-Myers Squibb Company; 2009.
13. Ahlskog JE, Muenter MD, McManis PG, Bell GN, Bailey PA. Controlled-release Sinemet (CR-4): a double-blind crossover study in patients with fluctuating Parkinson's disease. Mayo Clin Proc. 1988;63:876-86.
14. Hutton JT, Morris JL, Roman GC, Imke SC, Elias JW. Treatment of chronic Parkinson's disease with controlled-release carbidopa/levodopa. Arch Neurol. 1988;45:861-4.
15. Jankovic J, Schwartz K, Vander Linden C. Comparison of Sinemet CR4 and standard Sinemet: double-blind and long-term open trial in parkinsonian patients with fluctuations. Mov Disord. 1989;4:303-9.
16. Lieberman A, Gopinathan G, Miller E, Neophytides A, Baumann G, Chin L. Randomized double-blind cross-over study of Sinemet controlled release (CR4 50/200) versus Sinemet 25/100 in Parkinson's disease. Eur Neurol. 1990;30:75-8.
17. Pahwa R, Factor SA, Lyons KE, et al. Practice parameter: treatment of Parkinson disease with motor fluctuations and dyskinesia (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006;66:983-95.
18. Cedarbaum JM, Hoey M, McDowell FH. A double-blind crossover comparison of Sinemet CR4 and standard Sinemet 25/100 in patients with Parkinson's disease and fluctuating motor performance. J Neurol Neurosurg Psychiatry. 1989;52:207-12.
19. Sage JI, Mark MH. Comparison of controlled-release Sinemet (CR4) and standard Sinemet (25 mg/100 mg) in advanced Parkinson's disease: a double-blind, crossover study. Clin Neuropharmacol. 1988;11:174-9.
20. Deleu D, Jacques M, Michotte Y, Ebinger G. Controlled-release carbidopa/levodopa (CR) in parkinsonian patients with response fluctuations on standard levodopa treatment: clinical and pharmacokinetic observations. Neurology. 1989;39(Suppl 2):88-92.
21. Stocchi F, Quinn NP, Barbato L, et al. Comparison between a fast and a slow release preparation of levodopa and a combination of the two: a clinical and pharmacokinetic study. Clin Neuropharmacol. 1994;17:38-44.
22. Hauser RA. IPX066: a novel carbidopa-levodopa extended-release formulation. Expert Rev Neurother. 2012;12:133-40.
23. 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;26:2246-52.
24. Pahwa R, Lyons KE, Hauser RA, et al. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord. 2014;20:142-8.
25. Hauser RA, Hsu A, Kell S, et al. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial. Lancet Neurol. 2013;12:346-56.
26. Azilect prescribing information. 2014. http://www.azilect.com/Resources/pdf/PrescribingInformation.pdf. Accessed 2 Oct 2014.
27. IMPAX Laboratories, Inc. An open label extension study of the safety and clinical utility of IPX066 in subjects with Parkinson's disease [ClinicalTrials.gov identifier NCT01096186]. US National Institutes of Health, ClinicalTrials.gov. http://www.clinicaltrials.gov. Accessed 24 Mar 2015.
28. Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014;311:1670-83.
29. Fernandez HH, Vanagunas A, Odin P, et al. Levodopa-carbidopa intestinal gel in advanced Parkinson's disease open-label study: interim results. Parkinsonism Relat Disord. 2013;19:339-45.
30. Olanow CW, Kieburtz K, Odin P, et al. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol. 2014;13:141-9.
31. Whone AL, Watts RL, Stoessl AJ, et al. Slower progression of Parkinson's disease with ropinirole versus levodopa: the REAL-PET study. Ann Neurol. 2003;54:93-101.
32. Hauser RA, Rascol O, Korczyn AD, et al. Ten-year follow-up of Parkinson's disease patients randomized to initial therapy with ropinirole or levodopa. Mov Disord. 2007;22:2409-17.
33. Katzenschlager R, Head J, Schrag A, et al. Fourteen-year final report of the randomized PDRG-UK trial comparing three initial treatments in PD. Neurology. 2008;71:474-80.
34. Parkinson Study Group. Entacapone improves motor fluctuations in levodopa-treated Parkinson's disease patients. Ann Neurol. 1997;42:747-55.