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: July 19, 2016
Last verified: July 2016

April 15, 2008
July 19, 2016
November 2009
September 2020   (final data collection date for primary outcome measure)
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.
Adverse events [ Time Frame: Until commerical availability ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00660673 on ClinicalTrials.gov Archive Site
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.

CGI-I, PDQ 39 [ Time Frame: Until commerical availability ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD
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
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).
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Parkinson's Disease
  • 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
Experimental: 1
Levodopa-carbidopa intestinal gel
Interventions:
  • Drug: Levodopa-carbidopa intestinal gel
  • Device: CADD-Legacy® 1400 ambulatory infusion pump
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
261
September 2020
September 2020   (final data collection date for primary outcome measure)

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.

Both
30 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Czech Republic,   Israel,   New Zealand,   Poland,   Portugal,   Russian Federation,   Thailand,   United Kingdom
 
NCT00660673
S187.3.005, 2008-001329-33
No
Not Provided
Not Provided
AbbVie (prior sponsor, Abbott)
AbbVie (prior sponsor, Abbott)
Quintiles, Inc.
Study Director: Janet Benesh AbbVie
AbbVie
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP