Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson's Disease

David G. Standaert; Ramon L. Rodriguez; John T. Slevin; Michael Lobatz; Susan Eaton; Krai Chatamra; Maurizio F. Facheris; Coleen Hall; Kavita Sail; Yash J. Jalundhwala; Janet Benesh

doi:10.1002/mdc3.12526

Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson's Disease

David G. Standaert, Ramon L. Rodriguez, John T. Slevin, Michael Lobatz, Susan Eaton, Krai Chatamra, Maurizio F. Facheris, Coleen Hall, Kavita Sail, Yash J. Jalundhwala, Janet Benesh

Research output: Contribution to journal › Article › peer-review

45 Scopus citations

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	https://doi.org/10.1002/mdc3.12526
State	Published - Nov 1 2017

Bibliographical note

Publisher Copyright:
© 2017 The Authors. Movement Disorders Clinical Practice published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Funding

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.

Funders	Funder number
Abbvie, Inc.
Alabama Department of Commerce
American Parkinson’s Disease Association
National Institutes of Health (NIH)	P20NS087997, R25NS079188, P30NS047466, P2CHD086851
AbbVie
University of Alabama

Keywords

LCIG
Levodopa
Parkinson's disease
non-motor symptoms
quality of life

ASJC Scopus subject areas

Neurology
Clinical Neurology

Access to Document

10.1002/mdc3.12526

Cite this

@article{7672c2ee196541c1bdc83ee4c0dabe84,

title = "Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson's Disease",

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.",

keywords = "LCIG, Levodopa, Parkinson's disease, non-motor symptoms, quality of life",

author = "Standaert, {David G.} and Rodriguez, {Ramon L.} and Slevin, {John T.} and Michael Lobatz and Susan Eaton and Krai Chatamra and Facheris, {Maurizio F.} and Coleen Hall and Kavita Sail and Jalundhwala, {Yash J.} and Janet Benesh",

note = "Publisher Copyright: {\textcopyright} 2017 The Authors. Movement Disorders Clinical Practice published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.",

year = "2017",

month = nov,

day = "1",

doi = "10.1002/mdc3.12526",

language = "English",

volume = "4",

pages = "829--837",

number = "6",

}

TY - JOUR

T1 - Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson's Disease

AU - Standaert, David G.

AU - Rodriguez, Ramon L.

AU - Slevin, John T.

AU - Lobatz, Michael

AU - Eaton, Susan

AU - Chatamra, Krai

AU - Facheris, Maurizio F.

AU - Hall, Coleen

AU - Sail, Kavita

AU - Jalundhwala, Yash J.

AU - Benesh, Janet

PY - 2017/11/1

Y1 - 2017/11/1

N2 - 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.

AB - 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.

KW - LCIG

KW - Levodopa

KW - Parkinson's disease

KW - non-motor symptoms

KW - quality of life

UR - http://www.scopus.com/inward/record.url?scp=85048445726&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85048445726&partnerID=8YFLogxK

U2 - 10.1002/mdc3.12526

DO - 10.1002/mdc3.12526

M3 - Article

AN - SCOPUS:85048445726

VL - 4

SP - 829

EP - 837

JO - Movement Disorders Clinical Practice

JF - Movement Disorders Clinical Practice

IS - 6

ER -

Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson's Disease

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this