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

Fabrizio Stocchi, Ann Hsu, Sarita Khanna, Aaron Ellenbogen, Andreas Mahler, Grace Liang, Ulrich Dillmann, Robert Rubens, Sherron Kell, Suneel Gupta

Research output: Contribution to journalArticle

Abstract

Background: IPX066, an investigational extended-release carbidopa-levodopa (CD-LD) preparation, has demonstrated a rapid attainment and prolonged maintenance of therapeutic LD plasma concentrations in advanced Parkinson's disease (PD). This phase-3 crossover study assessed its efficacy and safety vs. CD-LD plus entacapone (CL+E). Methods: At baseline, all patients had motor fluctuations despite a stable regimen of CL+E or CD-LD-entacapone combination tablets (CLE). The study included a 6-week conversion from CL+E or CLE to IPX066, followed by two 2-week, double-blind crossover treatment periods in randomized order, one on IPX066 (and placebo CL+E), the other on CL+E (and placebo IPX066), separated by 1-week open-label IPX066 treatment. The primary efficacy measure was mean percent daily "off" time during waking hours (from patient diaries). Results: Of 91 randomized patients, 84 completed the study. Their median daily LD dosage was 1495mg from IPX066 and 600mg from CL+E, corresponding, after correction for bioavailability, to an approximately 22% higher LD exposure on IPX066. Compared with CL+E, IPX066 demonstrated a lower percent "off" time (24.0% vs. 32.5%; p

Original languageEnglish
Pages (from-to)1335-1340
Number of pages6
JournalParkinsonism and Related Disorders
Volume20
Issue number12
DOIs
Publication statusPublished - Dec 1 2014

Keywords

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

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Clinical Neurology
  • Neurology

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    Stocchi, F., Hsu, A., Khanna, S., Ellenbogen, A., Mahler, A., Liang, G., Dillmann, U., Rubens, R., Kell, S., & Gupta, S. (2014). Comparison of IPX066 with carbidopa-levodopa plus entacapone in advanced PD patients. Parkinsonism and Related Disorders, 20(12), 1335-1340. https://doi.org/10.1016/j.parkreldis.2014.08.004