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
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00660673
First received: April 15, 2008
Last updated: July 10, 2014
Last verified: July 2014
  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:
  • The primary objective is continued access to LCIG treatment [ Time Frame: Until commerical availability ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Objectives: To assess the long-term safety and tolerability of the LCIG therapeutic system, and to assess the maintenance of efficacy using data collected from US subjects [ Time Frame: Until commercial availability ] [ Designated as safety issue: Yes ]

    Evaluation of physical exams, neurological exams, vitals, ECGs, clinical lab assessments, concomitant medication usage, monitoring complications of the infusion device, adverse event monitoring, tolerability assessed by the number of subjects who complete the study.

    Maintenance of efficacy will be assessed 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: May 2015
Estimated Primary Completion Date: May 2015 (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 and older
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
Locations
United States, Alabama
Site Reference ID/Investigator# 49941
Birmingham, Alabama, United States, 35222
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# 49930
Chicago, Illinois, United States, 60612
Site Reference ID/Investigator# 49944
Chicago, Illinois, United States, 60611
United States, Kentucky
Site Reference ID/Investigator# 49940
Lexington, Kentucky, United States, 40536
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# 49943
New York, New York, United States, 10032
Site Reference ID/Investigator# 49942
New York, New York, United States, 10029
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
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, 1010
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# 50107
St. Petersburg, Russian Federation, 197089
Site Reference ID/Investigator# 50103
St. Petersburg, Russian Federation, 194044
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
Investigators
Study Director: Janet Benesh AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( 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 10, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
United States: Food and Drug Administration
New Zealand: Medsafe
Portugal: National Pharmacy and Medicines Institute
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Israel: Ministry of Health
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AbbVie:
Levodopa
Dyskinesia
Carbidopa
levodopa/carbidopa intestinal gel
Parkinson's Disease
Severe Motor Fluctuations

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Carbidopa
Carbidopa, levodopa drug combination
Levodopa
Adjuvants, Immunologic
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014