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: July 19, 2016
Last verified: July 2016
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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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label 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:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Adverse Events [ Time Frame: Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
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 2009 |
| Estimated Study Completion Date: | September 2020 |
| Estimated Primary Completion Date: | September 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) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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
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Locations
| United States, Alabama | |
| Site Reference ID/Investigator# 49941 | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Site Reference ID/Investigator# 49915 | |
| Fountain Valley, California, United States, 92708 | |
| Site Reference ID/Investigator# 49913 | |
| Los Angeles, California, United States, 90033 | |
| Site Reference ID/Investigator# 49928 | |
| Oceanside, California, United States, 92056 | |
| United States, Colorado | |
| Site Reference ID/Investigator# 49927 | |
| Englewood, Colorado, United States, 80113 | |
| United States, District of Columbia | |
| Site Reference ID/Investigator# 49931 | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Site Reference ID/Investigator# 49929 | |
| Bradenton, Florida, United States, 34205 | |
| Site Reference ID/Investigator# 49918 | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Site Reference ID/Investigator# 49935 | |
| Gainesville, Florida, United States, 32607 | |
| Site Reference ID/Investigator# 49922 | |
| Jacksonville, Florida, United States, 32209 | |
| Site Reference ID/Investigator# 49916 | |
| Port Charlotte, Florida, United States, 33890 | |
| Site Reference ID/Investigator# 49919 | |
| Tampa, Florida, United States, 33613 | |
| United States, Georgia | |
| Site Reference ID/Investigator# 49938 | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Site Reference ID/Investigator# 49944 | |
| Chicago, Illinois, United States, 60611 | |
| Site Reference ID/Investigator# 49930 | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kentucky | |
| Site Reference ID/Investigator# 49940 | |
| Lexington, Kentucky, United States, 40536-0284 | |
| United States, Louisiana | |
| Site Reference ID/Investigator# 49945 | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maryland | |
| Site Reference ID/Investigator# 49934 | |
| Baltimore, Maryland, United States, 21201 | |
| Site Reference ID/Investigator# 49937 | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| Site Reference ID/Investigator# 49933 | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Site Reference ID/Investigator# 49911 | |
| Omaha, Nebraska, United States, 68198-2045 | |
| United States, New York | |
| Site Reference ID/Investigator# 49932 | |
| Manhasset, New York, United States, 11030 | |
| Site Reference ID/Investigator# 49942 | |
| New York, New York, United States, 10029 | |
| Site Reference ID/Investigator# 49943 | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Site Reference ID/Investigator# 49923 | |
| Raleigh, North Carolina, United States, 27607 | |
| Site Reference ID/Investigator# 49939 | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Site Reference ID/Investigator# 49914 | |
| Cincinnati, Ohio, United States, 45267-0525 | |
| Site Reference ID/Investigator# 76173 | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Vermont | |
| Site Reference ID/Investigator# 49912 | |
| Burlington, Vermont, United States, 05401 | |
| United States, Washington | |
| Site Reference ID/Investigator# 49917 | |
| Kirkland, Washington, United States, 98034 | |
| United States, Wisconsin | |
| Site Reference ID/Investigator# 49924 | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia | |
| Site Reference ID/Investigator# 50083 | |
| Adelaide, Australia, 5000 | |
| Site Reference ID/Investigator# 50082 | |
| Heidelberg, Australia, 3084 | |
| Site Reference ID/Investigator# 50081 | |
| Westmead, Australia, 2145 | |
| Canada | |
| Site Reference ID/Investigator# 78476 | |
| Edmonton, Canada, T6G 2B7 | |
| Site Reference ID/Investigator# 74513 | |
| Montreal, Canada, H2L 4M1 | |
| Site Reference ID/Investigator# 75913 | |
| Toronto, Canada, M5T 2S8 | |
| Czech Republic | |
| Site Reference ID/Investigator# 50085 | |
| Brno, Czech Republic, 656 91 | |
| Site Reference ID/Investigator# 50088 | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Site Reference ID/Investigator# 50087 | |
| Pardubice, Czech Republic, 532 03 | |
| Site Reference ID/Investigator# 50086 | |
| Prague 2, Czech Republic, 128 08 | |
| Site Reference ID/Investigator# 50084 | |
| Prague 5, Czech Republic, 15006 | |
| Israel | |
| Site Reference ID/Investigator# 50089 | |
| Tel Aviv, Israel, 64239 | |
| New Zealand | |
| Site Reference ID/Investigator# 50093 | |
| Auckland, New Zealand, 1023 | |
| Site Reference ID/Investigator# 50090 | |
| Christchurch, New Zealand, 8011 | |
| Site Reference ID/Investigator# 50091 | |
| Hamilton, New Zealand, 3204 | |
| Site Reference ID/Investigator# 50092 | |
| Wellington, New Zealand, 6002 | |
| Poland | |
| Site Reference ID/Investigator# 50096 | |
| Lodz, Poland, 93-113 | |
| Site Reference ID/Investigator# 50094 | |
| Poznan, Poland, 61-485 | |
| Portugal | |
| Site Reference ID/Investigator# 50098 | |
| Coimbra, Portugal, 3000-075 | |
| Site Reference ID/Investigator# 50099 | |
| Lisbon, Portugal, 1649-035 | |
| Site Reference ID/Investigator# 50101 | |
| Porto, Portugal, 4200-319 | |
| Russian Federation | |
| Site Reference ID/Investigator# 50104 | |
| Kazan, Russian Federation, 420061 | |
| Site Reference ID/Investigator# 50102 | |
| Moscow, Russian Federation, 125367 | |
| Site Reference ID/Investigator# 50103 | |
| St. Petersburg, Russian Federation, 194044 | |
| Site Reference ID/Investigator# 50107 | |
| St. Petersburg, Russian Federation, 197089 | |
| Site Reference ID/Investigator# 50106 | |
| St. Petersburg, Russian Federation, 197706 | |
| Thailand | |
| Site Reference ID/Investigator# 50108 | |
| Bangkok, Thailand, 10330 | |
| Site Reference ID/Investigator# 50109 | |
| Bangkok, Thailand, 10700 | |
| United Kingdom | |
| Site Reference ID/Investigator# 50003 | |
| Liverpool, United Kingdom, L9 7LJ | |
| Site Reference ID/Investigator# 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 |
| Study First Received: | April 15, 2008 |
| Last Updated: | July 19, 2016 |
| Health Authority: | Thailand: Ministry of Public Health Portugal: National Pharmacy and Medicines Institute Canada: Health Canada Czech Republic: State Institute for Drug Control United States: Food and Drug Administration Israel: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products United Kingdom: Medicines and Healthcare Products Regulatory Agency New Zealand: Medsafe Russia: Ministry of Health of the Russian Federation |
Keywords provided by AbbVie:
|
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 Carbidopa Levodopa 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 September 29, 2016