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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00660673




Registration number
NCT00660673
Ethics application status
Date submitted
15/04/2008
Date registered
17/04/2008

Titles & IDs
Public title
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
Scientific title
Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies
Secondary ID [1] 0 0
2008-001329-33
Secondary ID [2] 0 0
S187.3.005
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 - CADD-Legacy® 1400 ambulatory infusion pump
Treatment: Devices - Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

Experimental: Levodopa-Carbidopa Intestinal Gel - Initial dosing is based on the dosing regimen that the participant received during the previous LCIG study. Dosing is individually optimized and can be adjusted at any time during the study as clinically indicated. The total dose/day of LCIG is composed of 3 individually adjusted doses. The morning dose is administered as a bolus infusion, usually 5 to 10 mL (100 to 200 mg levodopa). The maintenance dose is adjustable in steps of 2 mg/hour (0.1 mL/hour), within a range of 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). Participants will be allowed to self-administer extra doses of LCIG to address immediate medical needs, normally 0.5 to 2.0 mL.

Participants will receive LCIG until it is commercially available.


Treatment: Drugs: Levodopa-Carbidopa Intestinal Gel (LCIG)
LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.

Treatment: Devices: CADD-Legacy® 1400 ambulatory infusion pump
Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.

Treatment: Devices: Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)
All participants previously had a PEG-J placed in one of the prior LCIG studies.
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
Number of Participants With Treatment-emergent Adverse Events
Timepoint [1] 0 0
From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).
Secondary outcome [1] 0 0
Number of Participants With Device Complications
Timepoint [1] 0 0
From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days.
Secondary outcome [2] 0 0
Number of Participants With Sleep Attacks
Timepoint [2] 0 0
Baseline (final assessment period of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.
Secondary outcome [3] 0 0
Number of Participants With Intense Impulsive Behavior
Timepoint [3] 0 0
Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.
Secondary outcome [4] 0 0
Number of Participants Who Developed Melanoma
Timepoint [4] 0 0
Once per year during the study; median duration of treatment was 1178 days.
Secondary outcome [5] 0 0
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI)
Timepoint [5] 0 0
From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).
Secondary outcome [6] 0 0
Number of Participants With Any Suicidal Ideation or Behavior
Timepoint [6] 0 0
Every 6 months (beginning with implementation of Protocol Amendment 3) until final visit; median duration of treatment was 1178 days.
Secondary outcome [7] 0 0
Number of Participants With Potentially Clinically Significant Vital Sign Values
Timepoint [7] 0 0
Baseline and every 6 months until final visit; median duration of treatment was 1178 days.
Secondary outcome [8] 0 0
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values
Timepoint [8] 0 0
Baseline and every 6 months until final visit; median duration of treatment was 1178 days.
Secondary outcome [9] 0 0
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values
Timepoint [9] 0 0
Baseline and every 6 months until final visit; median duration of treatment was 1178 days.
Secondary outcome [10] 0 0
Number of Participants With Vitamin Levels Outside of the Normal Range
Timepoint [10] 0 0
Every 6 months (beginning with implementation of Protocol Amendment 2) until final visit; median duration of treatment was 1178 days.
Secondary outcome [11] 0 0
Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year
Timepoint [11] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10, > Year 10 (maximum time on treatment was approximately 11.5 years).
Secondary outcome [12] 0 0
Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment
Timepoint [12] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [13] 0 0
Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment
Timepoint [13] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [14] 0 0
Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment
Timepoint [14] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [15] 0 0
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment
Timepoint [15] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [16] 0 0
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment
Timepoint [16] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [17] 0 0
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment
Timepoint [17] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [18] 0 0
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment
Timepoint [18] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [19] 0 0
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment
Timepoint [19] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [20] 0 0
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment
Timepoint [20] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Secondary outcome [21] 0 0
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment
Timepoint [21] 0 0
Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Eligibility
Key inclusion criteria
* The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG.
* For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
* The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations.
Minimum age
30 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
13/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2021
Sample size
Target
Accrual to date
Final
262
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital /ID# 50081 - Westmead
Recruitment hospital [2] 0 0
Royal Adelaide Hospital /ID# 50083 - Adelaide
Recruitment hospital [3] 0 0
Austin Hospital /ID# 50082 - Heidelberg
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Vermont
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Czechia
State/province [22] 0 0
Brno
Country [23] 0 0
Czechia
State/province [23] 0 0
Hradec Králové
Country [24] 0 0
Czechia
State/province [24] 0 0
Pardubice
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha
Country [26] 0 0
Israel
State/province [26] 0 0
Tel-Aviv
Country [27] 0 0
New Zealand
State/province [27] 0 0
Waikato
Country [28] 0 0
New Zealand
State/province [28] 0 0
Auckland
Country [29] 0 0
New Zealand
State/province [29] 0 0
Christchurch
Country [30] 0 0
New Zealand
State/province [30] 0 0
Wellington
Country [31] 0 0
Poland
State/province [31] 0 0
Lodzkie
Country [32] 0 0
Poland
State/province [32] 0 0
Wielkopolskie
Country [33] 0 0
Portugal
State/province [33] 0 0
Coimbra
Country [34] 0 0
Portugal
State/province [34] 0 0
Lisboa
Country [35] 0 0
Portugal
State/province [35] 0 0
Porto
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Kazan
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moscow
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Saint Petersburg
Country [39] 0 0
Thailand
State/province [39] 0 0
Bangkok
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Liverpool
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
IQVIA, formerly Quintiles
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Fernandez HH, Boyd JT, Fung VSC, Lew MF, Rodriguez... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT00660673