Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00360568
First received: August 3, 2006
Last updated: October 25, 2013
Last verified: October 2013

August 3, 2006
October 25, 2013
June 2009
October 2012   (final data collection date for primary outcome measure)
Long-term safety of LCIG over a 12-month period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Safety data during long-term treatment
Complete list of historical versions of study NCT00360568 on ClinicalTrials.gov Archive Site
Mean daily 'off' time (hours), UPDRS, CGI-I, PDQ 39 and EQ-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in mean daily “off” time (hours), based on the three consecutive day average “off” time for the diary at endpoint.
Not Provided
Not Provided
 
Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dyskinesias
  • Parkinson's Disease
  • Severe Motor Fluctuations
  • 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.
 
Completed
62
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Idiopathic parkinson's disease (PD) according to UKPDS Brain Bank Criteria;
  • Levodopa-responsive with severe motor fluctuations;
  • Completion of protocol S187.3.001 or S187.3.002 and continue to meet the inclusion criteria for the preceding study

Exclusion Criteria:

  • Patients with medically relevant abnormal findings (labs, ECG, physical examination, AEs, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (week 12) of study S187.3.001 or S187.3.002
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   New Zealand
 
NCT00360568
S187.3.003, 2006-000578-53
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Quintiles
Study Director: Janet Benesh AbbVie
AbbVie
October 2013

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