Comparison of IPX066 with carbidopa-levodopa plus entacapone in advanced PD patients

Parkinsonism and Related Disorders

Volumn 20, Issue 12, 2014, Pages 1335-1340

  Stocchi, Fabrizio ^a   Hsu, Ann ^b   Khanna, Sarita ^b   Ellenbogen, Aaron ^c   Mahler, Andreas ^d   Liang, Grace ^e   Dillmann, Ulrich ^f   Rubens, Robert ^b   Kell, Sherron ^b   Gupta, Suneel ^b  

^a IRCCS SAN RAFFAELE PISANA   (Italy)

^b Impax Laboratories Inc   (United States)

^c Quest Research Institute   (United States)

^d Neurozentrum Achim   (Germany)

^e PARKINSON S INSTITUTE   (United States)

^f SAARLAND UNIVERSITY   (Germany)

Author keywords

"Off" time; Entacapone; IPX066; Levodopa; Motor fluctuations; Parkinson's disease

Indexed keywords

CARBIDOPA PLUS ENTACAPONE PLUS LEVODOPA; CARBIDOPA PLUS LEVODOPA; PLACEBO;

ADULT; ARTICLE; CONFUSION; CONSTIPATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEHYDRATION; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSKINESIA; DYSPEPSIA; FALLING; FEMALE; FOLLOW UP; GASTROENTERITIS; HEART ATRIUM FIBRILLATION; HUMAN; HYPERCALCEMIA; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NAUSEA; OPEN STUDY; PARKINSON DISEASE; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SCIATICA; TABLET; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WAKEFULNESS;

EID: 84916224460     PISSN: 13538020     EISSN: 18735126     Source Type: Journal    
DOI: 10.1016/j.parkreldis.2014.08.004     Document Type: Article

References (28)

1. Ahlskog J.E., Muenter M.D. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord 2001, 16:448-458.
2. Fahn S., Oakes D., Shoulson I., Kieburtz K., Rudolph A., Lang A., et al. Levodopa and the progression of Parkinson's disease. NEngl J Med 2004, 351:2498-2508.
3. Fahn S. Does levodopa slow or hasten the rate of progression of Parkinson's disease?. JNeurol 2005, 252(Suppl.4):IV37-IV42.
4. Olanow C.W., Obeso J.A., Stocchi F. Continuous dopamine-receptor treatment of Parkinson's disease: scientific rationale and clinical implications. Lancet Neurol 2006, 5:677-687.
5. deSouza R.M., Moro E., Lang A.E., Schapira A.H. Timing of deep brain stimulation in Parkinson disease: a need for reappraisal?. Ann Neurol 2013, 73:565-575.
6. Nutt J.G., Woodward W.R., Beckner R.M., Stone C.K., Berggren K., Carter J.H., et al. Effect of peripheral catechol-O-methyltransferase inhibition on the pharmacokinetics and pharmacodynamics of levodopa in parkinsonian patients. Neurology 1994, 44:913-919.
7. Heikkinen H., Varhe A., Laine T., Puttonen J., Kela M., Kaakkola S., et al. Entacapone improves the availability of L-dopa in plasma by decreasing its peripheral metabolism independent of L-dopa/carbidopa dose. Br J Clin Pharmacol 2002, 54:363-371.
8. Brooks D.J., Sagar H. Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinson's disease: a randomised, placebo controlled, double blind, six month study. JNeurol Neurosurg Psychiatr 2003, 74:1071-1079. UK-Irish Entacapone Study Group.
9. Rinne U.K., Larsen J.P., Siden A., Worm-Petersen J. Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations. Nomecomt Study Group. Neurology 1998, 51:1309-1314.
10. Kieburtz K., Hubble J. Benefits of COMT inhibitors in levodopa-treated parkinsonian patients: results of clinical trials. Neurology 2000, 55:S42-S45.
11. Fox S.H., Katzenschlager R., Lim S.Y., Ravina B., Seppi K., Coelho M., et al. The movement disorder society evidence-based medicine review update: treatments for the motor symptoms of Parkinson's disease. Mov Disord 2011, 26(Suppl.3):S2-S41.
12. ® (carbidopa levodopa and entacapone) tablets prescribing information April 2011, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
13. LeWitt P.A., Jennings D., Lyons K.E., Pahwa R., Rabinowicz A.L., Wang J., et al. Pharmacokinetic-pharmacodynamic crossover comparison of two levodopa extension strategies. Mov Disord 2009, 24:1319-1324.
14. Hauser R.A., Ellenbogen A.L., Metman L.V., Hsu A., O'Connell M.J., Modi N.B., et al. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov Disord 2011, 26:2246-2252.
15. Hauser R.A. IPX066: a novel carbidopa-levodopa extended-release formulation. Expert Rev Neurother 2012, 12:133-140.
16. Hughes A.J., Daniel S.E., Kilford L., Lees A.J. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. JNeurol Neurosurg Psychiatr 1992, 55:181-184.
17. Hauser R.A., Friedlander J., Zesiewicz T.A., Adler C.H., Seeberger L.C., O'Brien C.F., et al. Ahome diary to assess functional status in patients with Parkinson's disease with motor fluctuations and dyskinesia. Clin Neuropharmacol 2000, 23:75-81.
18. The EuroQol Group EuroQol-a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990, 16:199-208.
19. Ware J.E., Sherbourne C.D. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30:473-483.
20. Chaudhuri K.R., Pal S., DiMarco A., Whately-Smith C., Bridgman K., Mathew R., et al. The Parkinson's disease sleep scale: a new instrument for assessing sleep and nocturnal disability in Parkinson's disease. JNeurol Neurosurg Psychiatry 2002, 73:629-635.
21. Hauser R.A., Hsu A., Kell S., Espay A.J., Sethi K., Stacy M., 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, 12:346-356.
22. Relative bioavailability of IPX066 to carbidopa-levodopa formulations November 23, 2011, Impax Pharmaceuticals: data on file. Study IPXB08-10.
23. ® full prescribing information April 2011, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
24. AStudy to compare IPX066 and carbidopa/levodopa/entacapone (CLE) followed by an open-label safety study of IPX066 in advanced Parkinson's disease November 23, 2011, Impax Pharmaceuticals: data on file. Study IPX066-B09-06.
25. Wolters E.C., Tesselar H.J. International (NL-UK) double-blind study of sinemet CR and standard sinemet (25/100) in 170 patients with fluctuating Parkinson's disease. JNeurol 1996, 243:235-240.
26. Parkinson Study Group Entacapone improves motor fluctuations in levodopa-treated Parkinson's disease patients. Ann Neurol 1997, 42:747-755.
27. Olanow C.W., Kieburtz K., Odin P., Espay A.J., Standaert D.G., Fernandez H.H., 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, 13:141-149.
28. Nutt J.G., Holford N.H. The response to levodopa in Parkinson's disease: imposing pharmacological law and order. Ann Neurol 1996, 39:561-573.