Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations
2 other identifiers
interventional
35
2 countries
14
Brief Summary
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2009
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 17, 2008
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
January 16, 2015
CompletedJanuary 16, 2015
January 1, 2015
1.8 years
April 15, 2008
January 12, 2015
January 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in Average Daily Normalized "Off" Time
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.
Baseline, Week 12
Secondary Outcomes (23)
Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12
Baseline, Week 12
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12
Baseline, Week 12
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12
Baseline, Week 12
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12
Baseline, Week 12
Change From Baseline in UPDRS Part III Score at Week 12
Baseline, Week 12
- +18 more secondary outcomes
Study Arms (2)
Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo Capsules
EXPERIMENTALParticipants were randomized to LCIG (levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Placebo Gel + Levodopa-Carbidopa Capsules
ACTIVE COMPARATORParticipants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Interventions
infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour)
percutaneous endoscopic gastrostomy tube
jejunal tube
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
- Levodopa-responsive participants who demonstrate some identifiable 'on response,' established by Investigator observation
- Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated
You may not qualify if:
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
- Undergone surgery for the treatment of PD
- Contraindications to levodopa
- Subjects with any neurological deficit that may interfere with the study assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVie (prior sponsor, Abbott)lead
- Quintiles, Inc.collaborator
Study Sites (14)
Site Reference ID/Investigator# 45931
Birmingham, Alabama, 35222, United States
Site Reference ID/Investigator# 45910
Fountain Valley, California, 92708, United States
Site Reference ID/Investigator# 45925
Oceanside, California, 92056, United States
Site Reference ID/Investigator# 45912
Port Charlotte, Florida, 33890, United States
Site Reference ID/Investigator# 45935
Chicago, Illinois, 60611, United States
Site Reference ID/Investigator# 45930
Lexington, Kentucky, 40536, United States
Site Reference ID/Investigator# 45934
New York, New York, 10032, United States
Site Reference ID/Investigator# 45929
Winston-Salem, North Carolina, 27157, United States
Site Reference ID/Investigator# 45908
Cincinnati, Ohio, 45267, United States
Site Reference ID/Investigator# 45922
Cleveland, Ohio, 44195-0001, United States
Site Reference ID/Investigator# 45915
Kirkland, Washington, 98034, United States
Site Reference ID/Investigator# 45904
Auckland, 1010, New Zealand
Site Reference ID/Investigator# 45902
Christchurch, 8011, New Zealand
Site Reference ID/Investigator# 45905
Hamilton, 3204, New Zealand
Related Publications (3)
Shih TM, Sail KR, Jalundhwala YJ, Sullivan J, van Eijndhoven E, Zadikoff C, Marshall TS, Lakdawalla DN. The effect of functional status impairment on nursing home admission risk among patients with advanced Parkinson's disease. J Med Econ. 2020 Mar;23(3):297-307. doi: 10.1080/13696998.2019.1693383. Epub 2019 Nov 28.
PMID: 31779508DERIVEDLew MF, Slevin JT, Kruger R, Martinez Castrillo JC, Chatamra K, Dubow JS, Robieson WZ, Benesh JA, Fung VS. Initiation and dose optimization for levodopa-carbidopa intestinal gel: Insights from phase 3 clinical trials. Parkinsonism Relat Disord. 2015 Jul;21(7):742-8. doi: 10.1016/j.parkreldis.2015.04.022. Epub 2015 Apr 28.
PMID: 25962554DERIVEDOlanow CW, Kieburtz K, Odin P, Espay AJ, Standaert DG, Fernandez HH, Vanagunas A, Othman AA, Widnell KL, Robieson WZ, Pritchett Y, Chatamra K, Benesh J, Lenz RA, Antonini A; LCIG Horizon Study Group. 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 Feb;13(2):141-9. doi: 10.1016/S1474-4422(13)70293-X. Epub 2013 Dec 20.
PMID: 24361112DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie (prior sponsor, Abbott)
Study Officials
- STUDY DIRECTOR
Janet Benesh
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2008
First Posted
April 17, 2008
Study Start
December 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
January 16, 2015
Results First Posted
January 16, 2015
Record last verified: 2015-01