Abstract
Background: Levodopa-carbidopa intestinal gel (LCIG; carbidopa-levodopa enteral suspension in the United States), delivered via percutaneous gastrojejunostomy (PEG-J) and titrated in the inpatient setting, is an established treatment option for advanced Parkinson's disease (PD) patients with motor fluctuations. However, long-term prospective data on the efficacy of LCIG on non-motor symptoms and the safety of outpatient titration are limited. Methods: In this 60-week, open-label phase 3b study, LCIG titration was initiated in an outpatient setting following PEG-J placement in PD patients. The efficacy of LCIG on motor and non-motor symptoms, quality of life, and safety was assessed. Results: Thirty-nine patients were enrolled in the study and 28 patients completed the treatment. A majority of patients (54%) completed outpatient titration within the first week of LCIG infusion. LCIG led to significant reductions from baseline in Non-Motor Symptom Scale (NMSS) total score (least squares mean ± SE = −17.6 ± 3.6, P < 0.001) and 6 of the NMSS domain scores (sleep/fatigue, attention/memory, gastrointestinal tract, urinary, sexual function, miscellaneous) at week 12. These reductions were maintained at week 60 with the exception of the urinary domain. “Off” time (−4.9 ± 0.5 hours/day, P < 0.001) and “On” time without troublesome dyskinesia (−4.3 ± 0.6 hours/day, P < 0.001) were improved at week 60. Adverse events (AEs) were reported in 37 (95%) patients. Conclusions: LCIG treatment led to reductions in non-motor symptom burden and motor fluctuations in advanced PD patients. The safety profile was consistent with previous studies that used inpatient titration and outpatient titration did not appear to pose additional risk.
| Original language | English |
|---|---|
| Pages (from-to) | 829-837 |
| Number of pages | 9 |
| Journal | Movement Disorders Clinical Practice |
| Volume | 4 |
| Issue number | 6 |
| DOIs | |
| State | Published - Nov 1 2017 |
Bibliographical note
Funding Information:Ethical Compliance Statement: We, the authors, confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. Funding Sources and Conflict of Interest: Study-related disclosures: D.G.S., R.L.R., J.T.S., and M.L. were study investigators. D.G.S., J.T.S. were paid consultants to AbbVie for study design and medical/scientific advice. J.T.S. received research support from AbbVie. S.E. and K.C. are former Abb-Vie employees. M.F., C.H., K.S., Y.J.J., and J.B. are employees of AbbVie and own AbbVie stock/stock options. This work was funded by AbbVie Inc. AbbVie participated in the study design, research, data collection, analysis, and interpretation of data, writing, reviewing, and approving the publication. Medical writing support was provided by Amy M. Spiegel of AbbVie Inc. Financial disclosures from previous 12 months: D.G.S. is a member of the faculty of the University of Alabama at Birmingham and is supported by endowment and University funds. Dr. Standaert is an investigator in studies funded by Abbvie, Inc., the American Parkinson’s Disease Association, The Michael J. Fox Foundation for Parkinson’s Research, Alabama Department of Commerce, and NIH grants P01NS087997, P20NS087997, R25NS079188, P2CHD086851, and P30NS047466. He has a clinical practice and is compensated for these activities through the University of Alabama Health Services Foundation. In addition, since January 1, 2016 he has served as a consultant for or received honoraria from, Serina Therapeutics, Abbvie, Voyager Therapeutics, the Michael J.
Publisher Copyright:
© 2017 The Authors. Movement Disorders Clinical Practice published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.
Keywords
- LCIG
- Levodopa
- Parkinson's disease
- non-motor symptoms
- quality of life
ASJC Scopus subject areas
- Neurology
- Clinical Neurology