Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

Completed · Phase 3 · Has a placebo group

Conditions studied: Advanced Parkinson's Disease

In brief

The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.

Key facts

Study ID

NCT00660387

Run by

AbbVie (prior sponsor, Abbott)

People needed

35

Starts

2009-12-01

Expected to finish

2011-10-01

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 Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
• Levodopa-responsive participants who demonstrate some identifiable 'on response,' established by Investigator observation
• Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

You may not qualify if…

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
• Undergone surgery for the treatment of PD
• Contraindications to levodopa
• Subjects with any neurological deficit that may interfere with the study assessments

Where it is running

• Site Reference ID/Investigator# 45931 — Birmingham, Alabama, United States
• Site Reference ID/Investigator# 45910 — Fountain Valley, California, United States
• Site Reference ID/Investigator# 45925 — Oceanside, California, United States
• Site Reference ID/Investigator# 45912 — Port Charlotte, Florida, United States
• Site Reference ID/Investigator# 45935 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 45930 — Lexington, Kentucky, United States
• Site Reference ID/Investigator# 45934 — New York, New York, United States
• Site Reference ID/Investigator# 45929 — Winston-Salem, North Carolina, United States
• Site Reference ID/Investigator# 45908 — Cincinnati, Ohio, United States
• Site Reference ID/Investigator# 45922 — Cleveland, Ohio, United States
• Site Reference ID/Investigator# 45915 — Kirkland, Washington, United States
• Site Reference ID/Investigator# 45904 — Auckland, New Zealand
• Site Reference ID/Investigator# 45902 — Christchurch, New Zealand
• Site Reference ID/Investigator# 45905 — Hamilton, New Zealand

Full record on ClinicalTrials.gov

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