Status:
COMPLETED
Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Dyskinesias
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.
Detailed Description
Study S187.3.003 (NCT00360568) is a Phase 3, 12-month, open-label, multicenter continuation treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal gel (LCIG) in the...
Eligibility Criteria
Inclusion
- Idiopathic Parkinson's disease (PD) according to United Kingdon Parkinson's Disease Society (UKPDS) Brain Bank Criteria
- Levodopa-responsive with severe motor fluctuations
- Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and continue to meet the inclusion criteria for the preceding study
Exclusion
- Patients with medically relevant abnormal findings (labs, electrocardiogram \[ECG\], physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00360568
Start Date
June 1 2009
End Date
October 1 2012
Last Update
January 16 2015
Active Locations (22)
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1
Site Reference ID/Investigator# 45869
Birmingham, Alabama, United States, 35222
2
Site Reference ID/Investigator# 45834
Fountain Valley, California, United States, 92708
3
Site Reference ID/Investigator# 45854
Los Angeles, California, United States, 90033
4
Site Reference ID/Investigator# 45856
Oceanside, California, United States, 92056