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: October 20, 2014
Last verified: October 2014

April 15, 2008
October 20, 2014
November 2009
May 2015   (final data collection date for primary outcome measure)
The primary objective is continued access to LCIG treatment [ Time Frame: Until commerical availability ] [ Designated as safety issue: No ]
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
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

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
May 2015   (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 and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Australia,   Czech Republic,   Israel,   New Zealand,   Poland,   Portugal,   Russian Federation,   Thailand,   Canada
 
NCT00660673
S187.3.005, 2008-001329-33
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Quintiles
Study Director: Janet Benesh AbbVie
AbbVie
October 2014

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