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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00660387




Registration number
NCT00660387
Ethics application status
Date submitted
15/04/2008
Date registered
17/04/2008
Date last updated
16/01/2015

Titles & IDs
Public title
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Scientific title
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
Secondary ID [1] 0 0
2007-003814-32
Secondary ID [2] 0 0
S187.3.002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levodopa carbidopa intestinal gel (LCIG)
Treatment: Devices - PEG tube
Treatment: Devices - J-tube

Experimental: Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo Capsules - Participants 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.

Active comparator: Placebo Gel + Levodopa-Carbidopa Capsules - Participants 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.


Treatment: Drugs: Levodopa carbidopa intestinal gel (LCIG)
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)

Treatment: Devices: PEG tube
percutaneous endoscopic gastrostomy tube

Treatment: Devices: J-tube
jejunal tube
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 12 in Average Daily Normalized "Off" Time
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Change From Baseline in UPDRS Part III Score at Week 12
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Week 12
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12
Timepoint [10] 0 0
Baseline, Week 12
Secondary outcome [11] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12
Timepoint [11] 0 0
Baseline, Week 12
Secondary outcome [12] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12
Timepoint [12] 0 0
Baseline, Week 12
Secondary outcome [13] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12
Timepoint [13] 0 0
Baseline, Week 12
Secondary outcome [14] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12
Timepoint [14] 0 0
Baseline, Week 12
Secondary outcome [15] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12
Timepoint [15] 0 0
Baseline, Week 12
Secondary outcome [16] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12
Timepoint [16] 0 0
Baseline, Week 12
Secondary outcome [17] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12
Timepoint [17] 0 0
Baseline, Week 12
Secondary outcome [18] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12
Timepoint [18] 0 0
Baseline, Week 12
Secondary outcome [19] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12
Timepoint [19] 0 0
Baseline, Week 12
Secondary outcome [20] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12
Timepoint [20] 0 0
Baseline, Week 12
Secondary outcome [21] 0 0
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12
Timepoint [21] 0 0
Baseline, Week 12
Secondary outcome [22] 0 0
Employment Impairment (EMP) I Status at Baseline
Timepoint [22] 0 0
Baseline
Secondary outcome [23] 0 0
Employment Impairment (EMP) II Status at Week 12
Timepoint [23] 0 0
Week 12 (or early termination)

Eligibility
Key inclusion criteria
* 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
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Christchurch
Country [12] 0 0
New Zealand
State/province [12] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Quintiles, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00660387
Trial related presentations / publications
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.
Lew 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.
Olanow 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. Erratum In: Lancet Neurol. 2014 Mar;13(3):240.
Public notes

Contacts
Principal investigator
Name 0 0
Janet Benesh
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00660387