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

Completed · Phase 3

Conditions studied: Dyskinesias, Parkinson's Disease, Severe Motor Fluctuations

In brief

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

Key facts

Study ID

NCT00360568

Run by

AbbVie (prior sponsor, Abbott)

People needed

62

Starts

2009-06-01

Expected to finish

2012-10-01

Last updated by the study team

2015-01-16

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Site Reference ID/Investigator# 45869 — Birmingham, Alabama, United States
• Site Reference ID/Investigator# 45834 — Fountain Valley, California, United States
• Site Reference ID/Investigator# 45854 — Los Angeles, California, United States
• Site Reference ID/Investigator# 45856 — Oceanside, California, United States
• Site Reference ID/Investigator# 45859 — Washington D.C., District of Columbia, United States
• Site Reference ID/Investigator# 45857 — Bradenton, Florida, United States
• Site Reference ID/Investigator# 45863 — Gainesville, Florida, United States
• Site Reference ID/Investigator# 45836 — Port Charlotte, Florida, United States
• Site Reference ID/Investigator# 45874 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 45868 — Lexington, Kentucky, United States
• Site Reference ID/Investigator# 45862 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 45861 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 45873 — New York, New York, United States
• Site Reference ID/Investigator# 45878 — Cincinnati, Ohio, United States
• Site Reference ID/Investigator# 45850 — Cleveland, Ohio, United States
• Site Reference ID/Investigator# 45887 — Burlington, Vermont, United States
• Site Reference ID/Investigator# 45828 — Bochum, Germany
• Site Reference ID/Investigator# 45829 — Bremerhaven, Germany
• Site Reference ID/Investigator# 45825 — Hanover, Germany
• Site Reference ID/Investigator# 54402 — Tübingen, Germany
• Site Reference ID/Investigator# 45884 — Auckland, New Zealand
• Site Reference ID/Investigator# 45885 — Hamilton, New Zealand

Full record on ClinicalTrials.gov

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