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Trial record 1 of 1 for:
S187.3.005
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00660673
First received: April 15, 2008
Last updated: April 19, 2017
Last verified: April 2017
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel Device: CADD-Legacy® 1400 ambulatory infusion pump | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Primary Outcome Measures:
- Adverse Events [ Time Frame: Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country ]The number of participants with adverse events.
Secondary Outcome Measures:
- Long Term Safety and Maintenance of Efficacy [ Time Frame: Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country ]
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.
| Estimated Enrollment: | 261 |
| Study Start Date: | November 13, 2009 |
| Estimated Study Completion Date: | September 30, 2020 |
| Estimated Primary Completion Date: | September 15, 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Levodopa-carbidopa intestinal gel
|
Drug: 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);
Device: CADD-Legacy® 1400 ambulatory infusion pump
pump
|
Eligibility| Ages Eligible for Study: | 30 Years to 99 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660673
Hide Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660673
Hide Study Locations
Locations
| United States, Alabama | |
| University of Alabama at Birmington (UAB) /ID# 49941 | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Parkinson's and Movement Disorder Institute /ID# 49915 | |
| Fountain Valley, California, United States, 92708 | |
| University of Southern California /ID# 49913 | |
| Los Angeles, California, United States, 90033 | |
| The Research Center of Southern California /ID# 49928 | |
| Oceanside, California, United States, 92056 | |
| United States, Colorado | |
| Colorado Neurological Institute /ID# 49927 | |
| Englewood, Colorado, United States, 80113 | |
| United States, District of Columbia | |
| Georgetown University Hospital /ID# 49931 | |
| Washington, D.C., District of Columbia, United States, 20007 | |
| United States, Florida | |
| Bradenton Research Center, Inc. /ID# 49929 | |
| Bradenton, Florida, United States, 34205 | |
| Neurologic Consultants, PA /ID# 49918 | |
| Fort Lauderdale, Florida, United States, 33308 | |
| University of Florida /ID# 49935 | |
| Gainesville, Florida, United States, 32607 | |
| University of Florida /ID# 49922 | |
| Jacksonville, Florida, United States, 32209 | |
| Charlotte Neurological Services /ID# 49916 | |
| Port Charlotte, Florida, United States, 33890 | |
| University of South Florida /ID# 49919 | |
| Tampa, Florida, United States, 33613 | |
| United States, Georgia | |
| Augusta University /ID# 49938 | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Northwestern University /ID# 49944 | |
| Chicago, Illinois, United States, 60611 | |
| Rush University Medical Center /ID# 49930 | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kentucky | |
| University of Kentucky Medical Center /ID# 49940 | |
| Lexington, Kentucky, United States, 40536-0284 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center-Shreveport /ID# 49945 | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maryland | |
| University of Maryland School of Medicine /ID# 49934 | |
| Baltimore, Maryland, United States, 21201 | |
| The Johns Hopkins University Hospital /ID# 49937 | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| Washington University School of Medicine /ID# 49933 | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska Medical Center /ID# 49911 | |
| Omaha, Nebraska, United States, 68198-2045 | |
| United States, New York | |
| North Shore-Long Island Jewish Health System /ID# 49932 | |
| Manhasset, New York, United States, 11030 | |
| Mount Sinai Medical Center /ID# 49942 | |
| New York, New York, United States, 10029 | |
| Columbia University Medical Center /ID# 49943 | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Raleigh Neurology Associates, P.A. /ID# 49923 | |
| Raleigh, North Carolina, United States, 27607 | |
| Wake Forest University School /ID# 49939 | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| University of Cincinnati Physicians Company LLC /ID# 49914 | |
| Cincinnati, Ohio, United States, 45267-0525 | |
| Cleveland Clinic Foundation /ID# 76173 | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Vermont | |
| Fletcher Allen Health Care, Inc. /ID# 49912 | |
| Burlington, Vermont, United States, 05401 | |
| United States, Washington | |
| King County Public Hospital District 2 /ID# 49917 | |
| Kirkland, Washington, United States, 98034 | |
| United States, Wisconsin | |
| Medical College of Wisconsin at Froedtert Memorial Lutheran /ID# 49924 | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia | |
| Royal Adelaide Hospital /ID# 50083 | |
| Adelaide, Australia, 5000 | |
| Austin Hospital /ID# 50082 | |
| Heidelberg, Australia, 3084 | |
| Westmead Hospital /ID# 50081 | |
| Westmead, Australia, 2145 | |
| Canada | |
| Cross Cancer Institute, University of Alberta /ID# 78476 | |
| Edmonton, Canada, T6G 2B7 | |
| CHUM - Notre-Dame Hospital /ID# 74513 | |
| Montreal, Canada, H2L 4M1 | |
| Toronto Western Hospital /ID# 75913 | |
| Toronto, Canada, M5T 2S8 | |
| Czechia | |
| Fakultni Nemocnice u Svate Anny /ID# 50085 | |
| Brno, Czechia, 656 91 | |
| Fakultni Nemocnice Hradec Kralove /ID# 50088 | |
| Hradec Kralove, Czechia, 500 05 | |
| Multiscan s.r.o. /ID# 50087 | |
| Pardubice, Czechia, 532 03 | |
| VFN Prague /ID# 50086 | |
| Prague 2, Czechia, 128 08 | |
| Fakultni Nemocnice v Motole /ID# 50084 | |
| Prague 5, Czechia, 15006 | |
| Israel | |
| Ichilov Sourasky Medical Center /ID# 50089 | |
| Tel Aviv, Israel, 64239 | |
| New Zealand | |
| Auckland City Hospital /ID# 50093 | |
| Auckland, New Zealand, 1023 | |
| Van der Veer Institute for Parkinsons and Brain Research /ID# 50090 | |
| Christchurch, New Zealand, 8011 | |
| Waikato Hospital /ID# 50091 | |
| Hamilton, New Zealand, 3204 | |
| Wellington Hospital, Capital and Coast District Health Board /ID# 50092 | |
| Wellington, New Zealand, 6002 | |
| Poland | |
| III Szpital Miejski w Lodzi im. Dr K. Jonschera /ID# 50096 | |
| Lodz, Poland, 93-113 | |
| NZOZ Centrum Medyczne HCP /ID# 50094 | |
| Poznan, Poland, 61-485 | |
| Portugal | |
| Centro Hospitalar e Universitario de Coimbra, EPE /ID# 50098 | |
| Coimbra, Portugal, 3000-075 | |
| Hospital de Santa Maria /ID# 50099 | |
| Lisbon, Portugal, 1649-035 | |
| Centro Hospitalar de Sao Joao, E.P.E.(CHSJ-HSJ) /ID# 50101 | |
| Porto, Portugal, 4200-319 | |
| Russian Federation | |
| Ltd Liability Co Scientific Res Med Complex, Your Health /ID# 50104 | |
| Kazan, Russian Federation, 420061 | |
| State Inst Neurology RAMS /ID# 50102 | |
| Moscow, Russian Federation, 125367 | |
| Military Medical Academy na S.M. Kirov of Defense Russia /ID# 50103 | |
| St. Petersburg, Russian Federation, 194044 | |
| St. Petersburg Medical Univ na I.P. Pavlov /ID# 50107 | |
| St. Petersburg, Russian Federation, 197089 | |
| City Clinical Hospital #40 /ID# 50106 | |
| St. Petersburg, Russian Federation, 197706 | |
| Thailand | |
| King Chulalongkorn Memorial Hospital /ID# 50108 | |
| Bangkok, Thailand, 10330 | |
| Siriraj Hospital /ID# 50109 | |
| Bangkok, Thailand, 10700 | |
| United Kingdom | |
| Walton Centre for Neurology & Neurosurgery /ID# 50003 | |
| Liverpool, United Kingdom, L9 7LJ | |
| National Hospital for Neurology & Neurosurgery /ID# 50002 | |
| London, United Kingdom, WC1N 3BG | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Quintiles, Inc.
Investigators
| Study Director: | Janet Benesh | AbbVie |
More Information
Additional Information:
| Responsible Party: | AbbVie (prior sponsor, Abbott) |
| ClinicalTrials.gov Identifier: | NCT00660673 History of Changes |
| Other Study ID Numbers: |
S187.3.005 2008-001329-33 ( EudraCT Number ) |
| Study First Received: | April 15, 2008 |
| Last Updated: | April 19, 2017 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
|
levodopa/carbidopa intestinal gel Dyskinesia Carbidopa |
Parkinson's Disease Severe Motor Fluctuations Levodopa |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa Carbidopa Carbidopa, levodopa drug combination |
Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Aromatic Amino Acid Decarboxylase Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Dopamine Agonists |
ClinicalTrials.gov processed this record on June 23, 2017