Trial record 1 of 1 for:
S187.3.005
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00660673 |
|
Recruitment Status
:
Active, not recruiting
First Posted
: April 17, 2008
Last Update Posted
: February 16, 2018
|
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
- Study Details
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel Device: CADD-Legacy® 1400 ambulatory infusion pump | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 262 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | November 13, 2009 |
| Estimated Primary Completion Date : | September 15, 2020 |
| Estimated Study Completion Date : | September 30, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
|
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
|
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.
Information from the National Library of Medicine
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| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660673
Hide Study Locations
Locations
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| The Research Ctr Southern CA | |
| Encinitas, California, United States, 92024 | |
| Parkinson's and Movement | |
| Fountain Valley, California, United States, 92708 | |
| USC | |
| Los Angeles, California, United States, 90033 | |
| United States, Colorado | |
| Colorado Neurological Institut | |
| Englewood, Colorado, United States, 80113 | |
| United States, District of Columbia | |
| Medstar Georgetown Univ Med Ct | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Bradenton Research Center, Inc | |
| Bradenton, Florida, United States, 34205 | |
| Neurologic Consultants, PA | |
| Fort Lauderdale, Florida, United States, 33308 | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| University of Florida | |
| Jacksonville, Florida, United States, 32209 | |
| Charlotte Neurological Service | |
| Port Charlotte, Florida, United States, 33980 | |
| University of South Florida | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Georgia Regents University | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Rush Univ Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kentucky | |
| Univ Kentucky Med Ctr | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Louisiana | |
| Louisiana State Univ HSC | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Maryland | |
| Univ Maryland School Medicine | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| Washington University-School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Univ Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| North Shore University Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10032 | |
| Icahn School of Med Mt. Sinai | |
| New York, New York, United States, 10128 | |
| United States, North Carolina | |
| Raleigh Neurology Associates | |
| Raleigh, North Carolina, United States, 27607 | |
| Wake Forest Univ HS | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267-2827 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Vermont | |
| University of Vermont Medical Center | |
| Burlington, Vermont, United States, 05401 | |
| United States, Washington | |
| King County Public Hospital | |
| Kirkland, Washington, United States, 98034 | |
| United States, Wisconsin | |
| Froedtert and Medical College | |
| Milwaukee, Wisconsin, United States, 53226-3522 | |
| Australia, New South Wales | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Austin Hospital | |
| Heidelberg, Victoria, Australia, 3084 | |
| Canada, Newfoundland and Labrador | |
| University of Alberta | |
| Edmonton, Newfoundland and Labrador, Canada, T6G 2X8 | |
| Canada, Ontario | |
| Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| CHUM - Notre-Dame Hospital | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Czechia | |
| Fakultni Nemocnice u SvateAnny | |
| Brno, Czechia, 656 91 | |
| FN Hradec Kralove | |
| Hradec Kralove, Czechia, 500 05 | |
| Multiscan s.r.o. | |
| Pardubice, Czechia, 530-03 | |
| VFN Prague | |
| Prague, Czechia, 121 00 | |
| Fakultni Nemocnice v Motole | |
| Prague, Czechia, 150 00 | |
| Israel | |
| Tel Aviv Sourasky Medical Ctr | |
| Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906 | |
| New Zealand | |
| Waikato Hospital | |
| Hamilton, Waikato, New Zealand, 3204 | |
| Auckland City Hospital | |
| Auckland, New Zealand, 1023 | |
| Canterbury District Health Boa | |
| Christchurch, New Zealand, 8011 | |
| Wellington Hospital | |
| Wellington, New Zealand, 6021 | |
| Poland | |
| Szpital Miejski Dr Jonschera | |
| Lodz, Poland, 93-113 | |
| NZOZ Centrum Medyczne HCP | |
| Poznan, Poland, 61-485 | |
| Portugal | |
| Ctr Hosp Univ Coimbra, EPE | |
| Coimbra, Portugal, 3000-075 | |
| Hospital de Santa Maria | |
| Lisbon, Portugal, 1649-035 | |
| Centro Hospitalar de Sao Joao, EPE | |
| Porto, Portugal, 4200-319 | |
| Russian Federation | |
| Ltd Liability Co Scientific Re | |
| Kazan, Tatarstan, Respublika, Russian Federation, 420097 | |
| State Inst Neurology RAMS | |
| Moscow, Russian Federation, 125367 | |
| Military Med Academy SM Kirov | |
| St. Petersburg, Russian Federation, 194044 | |
| St. Petersburg State Medical U | |
| St. Petersburg, Russian Federation, 197022 | |
| City Clinical Hospital #40 | |
| St. Petersburg, Russian Federation, 197706 | |
| Thailand | |
| King Chulalongkorn Mem Hosp | |
| Bangkok, Thailand, 10330 | |
| Siriraj Hospital | |
| Bangkok, Thailand, 10700 | |
| United Kingdom | |
| The Walton Centre | |
| Liverpool, United Kingdom, L9 7LJ | |
| Nat Hosp Neurology & Surgery | |
| London, United Kingdom, WC1N 3BG | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Quintiles, Inc.
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
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 ) |
| First Posted: | April 17, 2008 Key Record Dates |
| Last Update Posted: | February 16, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
|
levodopa/carbidopa intestinal gel Severe Motor Fluctuations Levodopa |
Carbidopa Parkinson's Disease Dyskinesia |
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 |