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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00660673
Ethics application status
Date submitted
15/04/2008
Date registered
17/04/2008
Date last updated
16/06/2020

Titles & IDs
Public title
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD
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
Treatment: Devices - CADD-Legacy® 1400 ambulatory infusion pump

Experimental: 1 - Levodopa-carbidopa intestinal gel


Treatment: Drugs: Levodopa-carbidopa intestinal gel
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: CADD-Legacy® 1400 ambulatory infusion pump
pump

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
Adverse Events - The number of participants with adverse events.
Timepoint [1] 0 0
Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country
Secondary outcome [1] 0 0
Long Term Safety and Maintenance of Efficacy - Long term safety will be assessed by evaluating complications of the infusion device, Columbia-Suicide Severity Rating Scale (C-SSRS), and Minnesota Impulsive Disorders Interview (MIDI).
Maintenance of efficacy will be assessed using data collected from US subjects by evaluating the mean change from baseline in the following: Off time, On time with troublesome dyskinesia and On time without troublesome dyskinesia as measured by the Parkinson's Disease Diary; UPDRS total score, Parts I, II, III and IV scores; and dyskinesia item score PDQ-39 summary index and domain scores.
Timepoint [1] 0 0
Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country

Eligibility
Key inclusion criteria
- The subject 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, subjects 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 subject 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
subject does not have the capacity to provide informed consent, full informed consent
must be obtained from the subject's legally authorized representative. Consenting will
be performed according to local regulations.
Minimum age
30 Years
Maximum age
99 Years
Gender
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 subjects participation in
the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Praha 5
Country [23] 0 0
Czechia
State/province [23] 0 0
Brno
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Czechia
State/province [25] 0 0
Pardubice
Country [26] 0 0
Czechia
State/province [26] 0 0
Prague
Country [27] 0 0
Israel
State/province [27] 0 0
Tel-Aviv
Country [28] 0 0
New Zealand
State/province [28] 0 0
Waikato
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
New Zealand
State/province [30] 0 0
Christchurch
Country [31] 0 0
New Zealand
State/province [31] 0 0
Wellington
Country [32] 0 0
Poland
State/province [32] 0 0
Lodz
Country [33] 0 0
Poland
State/province [33] 0 0
Poznan
Country [34] 0 0
Portugal
State/province [34] 0 0
Coimbra
Country [35] 0 0
Portugal
State/province [35] 0 0
Lisbon
Country [36] 0 0
Portugal
State/province [36] 0 0
Porto
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Tatarstan, Respublika
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow
Country [39] 0 0
Russian Federation
State/province [39] 0 0
St. Petersburg
Country [40] 0 0
Thailand
State/province [40] 0 0
Bangkok
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Liverpool
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London

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 is to provide continued access to subjects who would like to continue
levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003
or S187.3.004).
Trial website
https://clinicaltrials.gov/show/NCT00660673
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

Summary results
Other publications