Levodopa-carbidopa intestinal gel in advanced Parkinson's disease open-label study: Interim results

Hubert H. Fernandez*, Arvydas Vanagunas, Per Odin, Alberto J. Espay, Robert A. Hauser, David G. Standaert, Krai Chatamra, Janet Benesh, Yili Pritchett, Steven L. Hass, Robert A. Lenz

*Corresponding author for this work

Research output: Contribution to journalArticle

68 Scopus citations

Abstract

Levodopa-carbidopa intestinal gel (LCIG) delivered continuously via percutaneous endoscopic gastrojejunostomy (PEG-J) tube has been reported, mainly in small open-label studies, to significantly alleviate motor complications in Parkinson's disease (PD). A prospective open-label, 54-week, international study of LCIG is ongoing in advanced PD patients experiencing motor fluctuations despite optimized pharmacologic therapy. Pre-planned interim analyses were conducted on all enrolled patients (n = 192) who had their PEG-J tube inserted at least 12 weeks before data cutoff (July 30, 2010). Outcomes include the 24-h patient diary of motor fluctuations, Unified Parkinson's Disease Rating Scale (UPDRS), Clinical Global Impression-Improvement (CGI-I), Parkinson's Disease Questionnaire (PDQ-39), and safety evaluations. Patients (average PD duration 12.4 yrs) were taking at least one PD medication at baseline. The mean (±SD) exposure to LCIG was 256.7 (±126.0) days. Baseline mean " Off" time was 6.7 h/day. " Off" time was reduced by a mean of 3.9 (±3.2) h/day and " On" time without troublesome dyskinesia was increased by 4.6 (±3.5) h/day at Week 12 compared to baseline. For the 168 patients (87.5%) reporting any adverse event (AE), the most common were abdominal pain (30.7%), complication of device insertion (21.4%), and procedural pain (17.7%). Serious AEs occurred in 60 (31.3%) patients. Twenty-four (12.5%) patients discontinued, including 14 (7.3%) due to AEs. Four (2.1%) patients died (none deemed related to LCIG). Interim results from this advanced PD cohort demonstrate that LCIG produced meaningful clinical improvements. LCIG was generally well-tolerated; however, device and procedural complications, while generally of mild severity, were common.

Original languageEnglish (US)
Pages (from-to)339-345
Number of pages7
JournalParkinsonism and Related Disorders
Volume19
Issue number3
DOIs
StatePublished - Mar 1 2013

Keywords

  • Levodopa-carbidopa intestinal gel
  • Motor fluctuations
  • PEG-J procedure
  • Parkinson's disease
  • Pump administration

ASJC Scopus subject areas

  • Neurology
  • Geriatrics and Gerontology
  • Clinical Neurology

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  • Cite this

    Fernandez, H. H., Vanagunas, A., Odin, P., Espay, A. J., Hauser, R. A., Standaert, D. G., Chatamra, K., Benesh, J., Pritchett, Y., Hass, S. L., & Lenz, R. A. (2013). Levodopa-carbidopa intestinal gel in advanced Parkinson's disease open-label study: Interim results. Parkinsonism and Related Disorders, 19(3), 339-345. https://doi.org/10.1016/j.parkreldis.2012.11.020