Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00335153




Registration number
NCT00335153
Ethics application status
Date submitted
8/06/2006
Date registered
9/06/2006
Date last updated
16/01/2015

Titles & IDs
Public title
Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease
Scientific title
An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications
Secondary ID [1] 0 0
2006-005186-18
Secondary ID [2] 0 0
S187.3.004
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 - PEG tube
Treatment: Devices - J-tube

Experimental: Levodopa-Carbidopa Intestinal Gel (LCIG) - All participants were to receive LCIG, via the NJ tube during the nasojejunal (NJ) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.


Treatment: Drugs: Levodopa-carbidopa intestinal gel
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
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs
Timepoint [1] 0 0
Screening through Day 378 + 30 days
Primary outcome [2] 0 0
Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period
Timepoint [2] 0 0
NJ Test Period (from 2 to 14 days)
Primary outcome [3] 0 0
Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods
Timepoint [3] 0 0
PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378)
Primary outcome [4] 0 0
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters
Timepoint [4] 0 0
Screening through Day 378
Primary outcome [5] 0 0
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters
Timepoint [5] 0 0
Screening through Day 378
Primary outcome [6] 0 0
Number of Participants With Potentially Clinically Significant Vital Sign Parameters
Timepoint [6] 0 0
up to 56 weeks
Primary outcome [7] 0 0
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters
Timepoint [7] 0 0
Screening through Day 378
Primary outcome [8] 0 0
Number of Participants With Sleep Attacks at Baseline
Timepoint [8] 0 0
Baseline
Primary outcome [9] 0 0
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period
Timepoint [9] 0 0
During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378)
Primary outcome [10] 0 0
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period
Timepoint [10] 0 0
Baseline, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378)
Primary outcome [11] 0 0
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint
Timepoint [11] 0 0
Baseline, Endpoint (last Post-PEG Long-Term Period visit up to Day 378)
Primary outcome [12] 0 0
Number of Participants With Confirmed Cases of Melanoma
Timepoint [12] 0 0
Screening up to Day 378
Primary outcome [13] 0 0
Number of Participants Taking at Least 1 Concomitant Medication During the Study
Timepoint [13] 0 0
Screening up to Day 378
Secondary outcome [1] 0 0
Change From Baseline in Average Daily "Off" Time at Endpoint
Timepoint [1] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [2] 0 0
Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint
Timepoint [2] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [3] 0 0
Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Endpoint
Timepoint [3] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [4] 0 0
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint
Timepoint [4] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [5] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12
Timepoint [5] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [6] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint
Timepoint [6] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [7] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint
Timepoint [7] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [8] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint
Timepoint [8] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [9] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint
Timepoint [9] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [10] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint
Timepoint [10] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [11] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint
Timepoint [11] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [12] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint
Timepoint [12] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [13] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint
Timepoint [13] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [14] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint
Timepoint [14] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [15] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint
Timepoint [15] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [16] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint
Timepoint [16] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [17] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint
Timepoint [17] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [18] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint
Timepoint [18] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [19] 0 0
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint
Timepoint [19] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [20] 0 0
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint
Timepoint [20] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)
Secondary outcome [21] 0 0
Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint
Timepoint [21] 0 0
Baseline, Endpoint (last post-baseline visit up to Day 378)

Eligibility
Key inclusion criteria
* Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
* Levodopa-responsive with severe motor fluctuations
* Recognizable off and on state (motor fluctuations) confirmed by diary
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 (such as narrow angle glaucoma)

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
354
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 46429 - Adelaide
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 46427 - Heidelberg
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 46425 - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
2145 - Westmead
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
Edmonton
Country [20] 0 0
Canada
State/province [20] 0 0
Montreal
Country [21] 0 0
Canada
State/province [21] 0 0
Toronto
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Brno
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Hradec Kralove
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Pardubice
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Prague 2
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Prague 5
Country [27] 0 0
Finland
State/province [27] 0 0
Lahti
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Freiburg
Country [30] 0 0
Germany
State/province [30] 0 0
Goettingen
Country [31] 0 0
Germany
State/province [31] 0 0
Hanau
Country [32] 0 0
Germany
State/province [32] 0 0
Hanover
Country [33] 0 0
Germany
State/province [33] 0 0
Mainz
Country [34] 0 0
Israel
State/province [34] 0 0
Tel Aviv
Country [35] 0 0
Italy
State/province [35] 0 0
Arcugnano
Country [36] 0 0
Italy
State/province [36] 0 0
Catania
Country [37] 0 0
Italy
State/province [37] 0 0
Genoa
Country [38] 0 0
Italy
State/province [38] 0 0
Lido di Camaiore
Country [39] 0 0
Italy
State/province [39] 0 0
Naples
Country [40] 0 0
Italy
State/province [40] 0 0
Rome
Country [41] 0 0
Netherlands
State/province [41] 0 0
Nijmegen
Country [42] 0 0
New Zealand
State/province [42] 0 0
Auckland
Country [43] 0 0
New Zealand
State/province [43] 0 0
Christchurch
Country [44] 0 0
New Zealand
State/province [44] 0 0
Hamilton
Country [45] 0 0
New Zealand
State/province [45] 0 0
Wellington
Country [46] 0 0
Poland
State/province [46] 0 0
Lodz
Country [47] 0 0
Poland
State/province [47] 0 0
Poznan
Country [48] 0 0
Portugal
State/province [48] 0 0
Almada
Country [49] 0 0
Portugal
State/province [49] 0 0
Coimbra
Country [50] 0 0
Portugal
State/province [50] 0 0
Lisbon
Country [51] 0 0
Portugal
State/province [51] 0 0
Porto
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Kazan
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Moscow
Country [54] 0 0
Russian Federation
State/province [54] 0 0
St. Petersburg
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Thailand
State/province [57] 0 0
Bangkok
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Liverpool
Country [59] 0 0
United Kingdom
State/province [59] 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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00335153