Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
NCT ID: NCT00660673
Last Updated: 2022-12-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
262 participants
INTERVENTIONAL
2009-11-13
2021-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
NCT00660387
Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
NCT00360568
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
NCT00357994
A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)
NCT02549092
A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications
NCT01960842
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
CADD-Legacy® 1400 ambulatory infusion pump
Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.
Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)
All participants previously had a PEG-J placed in one of the prior LCIG studies.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
CADD-Legacy® 1400 ambulatory infusion pump
Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.
Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)
All participants previously had a PEG-J placed in one of the prior LCIG studies.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
30 Years
99 Years
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IQVIA, formerly Quintiles
UNKNOWN
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham /ID# 49941
Birmingham, Alabama, United States
The Research Center of Southern California /ID# 49928
Encinitas, California, United States
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915
Fountain Valley, California, United States
Universtiy of Southern California /ID# 49913
Los Angeles, California, United States
Colorado Neurological Institute /ID# 49927
Englewood, Colorado, United States
Georgetown University Hospital /ID# 49931
Washington D.C., District of Columbia, United States
Bradenton Research Center, Inc /ID# 49929
Bradenton, Florida, United States
Neurologic Consultants, PA /ID# 49918
Fort Lauderdale, Florida, United States
University of Florida - Archer /ID# 49935
Gainesville, Florida, United States
University of Florida /ID# 49922
Jacksonville, Florida, United States
Charlotte Neurological Service /ID# 49916
Port Charlotte, Florida, United States
University of South Florida /ID# 49919
Tampa, Florida, United States
Georgia Regents University /ID# 49938
Augusta, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 49944
Chicago, Illinois, United States
Rush University Medical Center /ID# 49930
Chicago, Illinois, United States
University of Kentucky Chandler Medical Center /ID# 49940
Lexington, Kentucky, United States
Louisiana State Univ HSC /ID# 49945
Shreveport, Louisiana, United States
Univ Maryland School Medicine /ID# 49934
Baltimore, Maryland, United States
Johns Hopkins University /ID# 49937
Baltimore, Maryland, United States
Washington University-School of Medicine /ID# 49933
St Louis, Missouri, United States
University of Nebraska Medical Center /ID# 49911
Omaha, Nebraska, United States
North Shore University Hospital /ID# 49932
Manhasset, New York, United States
The Mount Sinai Hospital /ID# 49942
New York, New York, United States
Columbia Univ Medical Center /ID# 49943
New York, New York, United States
Raleigh Neurology Associates /ID# 49923
Raleigh, North Carolina, United States
Wake Forest Univ HS /ID# 49939
Winston-Salem, North Carolina, United States
University of Cincinnati /ID# 49914
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus /ID# 76173
Cleveland, Ohio, United States
University of Vermont Medical Center /ID# 49912
Burlington, Vermont, United States
King County Public Hospital /ID# 49917
Kirkland, Washington, United States
Froedtert Memorial Lutheran Hospital /ID# 49924
Milwaukee, Wisconsin, United States
Westmead Hospital /ID# 50081
Westmead, New South Wales, Australia
Royal Adelaide Hospital /ID# 50083
Adelaide, South Australia, Australia
Austin Hospital /ID# 50082
Heidelberg, Victoria, Australia
University of Alberta /ID# 78476
Edmonton, Alberta, Canada
Toronto Western Hospital /ID# 75913
Toronto, Ontario, Canada
CHUM - Notre-Dame Hospital /ID# 74513
Montreal, Quebec, Canada
Fakultni Nemocnice u Svate Anny /ID# 50085
Brno, , Czechia
Fakultni nemocnice Hradec Kralove /ID# 50088
Hradec Králové, , Czechia
Pardubicka krajska nemocnice, a.s.
Pardubice, , Czechia
Vseobecna fakultni nemocnice v Praze /ID# 50086
Prague, , Czechia
Fakultni Nemocnice v Motole /ID# 50084
Prague, , Czechia
Tel Aviv Sourasky Medical Center /ID# 50089
Tel Aviv, , Israel
Waikato Hospital /ID# 50091
Hamilton, Waikato Region, New Zealand
Auckland City Hospital /ID# 50093
Auckland, , New Zealand
New Zealand Brain Research Institute/ID# 50090
Christchurch, , New Zealand
Wellington Hospital /ID# 50092
Wellington, , New Zealand
NZOZ Centrum Medyczne HCP /ID# 50094
Poznan, Greater Poland Voivodeship, Poland
Miejskie Centrum Medyczne im. dr. Karola Jonschera w Lodzi /ID# 50096
Lodz, Łódź Voivodeship, Poland
Hospitais da Universidade de Coimbra /ID# 50098
Coimbra, , Portugal
Hospital de Santa Maria /ID# 50099
Lisbon, , Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 50101
Porto, , Portugal
Scientific Research Medical Complex Your Health /ID# 50104
Kazan', , Russia
Institution of the Russian Academy of Medical Sciences Scientific Centre of Neurology /ID# 50102
Moscow, , Russia
Military Medical Academy n.a. Kirov /ID# 50103
Saint Petersburg, , Russia
I.P. Pavlov First St. Petersburg State Medical University /ID# 50107
Saint Petersburg, , Russia
City Clinical Hospital #40 /ID# 50106
Saint Petersburg, , Russia
King Chulalongkorn Mem Hosp /ID# 50108
Bangkok, , Thailand
Siriraj Hospital /ID# 50109
Bangkok, , Thailand
The Walton Centre NHS Foundation /ID# 50003
Liverpool, , United Kingdom
National Hospital for Neurology & Neurosurgery
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fernandez HH, Boyd JT, Fung VSC, Lew MF, Rodriguez RL, Slevin JT, Standaert DG, Zadikoff C, Vanagunas AD, Chatamra K, Eaton S, Facheris MF, Hall C, Robieson WZ, Benesh J, Espay AJ. Long-term safety and efficacy of levodopa-carbidopa intestinal gel in advanced Parkinson's disease. Mov Disord. 2018 Jul;33(6):928-936. doi: 10.1002/mds.27338. Epub 2018 Mar 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-001329-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S187.3.005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.