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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

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:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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

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 :
  1. 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 :
  1. 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