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Trial record 1 of 1 for:    S187.3.005
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Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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:


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
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
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