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

NCT00357994

Run by

AbbVie (prior sponsor, Abbott)

People needed

36

Starts

2009-01-01

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# 45719 — Los Angeles, California, United States
• Site Reference ID/Investigator# 45718 — Englewood, Colorado, United States
• Site Reference ID/Investigator# 45722 — Washington D.C., District of Columbia, United States
• Site Reference ID/Investigator# 45721 — Bradenton, Florida, United States
• Site Reference ID/Investigator# 45705 — Gainesville, Florida, United States
• Site Reference ID/Investigator# 45740 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 45739 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 45703 — Burlington, Vermont, United States
• Site Reference ID/Investigator# 44970 — Bochum, Germany
• Site Reference ID/Investigator# 44971 — Bremerhaven, Germany
• Site Reference ID/Investigator# 44973 — Dresden, Germany
• Site Reference ID/Investigator# 44965 — Hanover, Germany
• Site Reference ID/Investigator# 44964 — Kiel, Germany
• Site Reference ID/Investigator# 44966 — Marburg, Germany
• Site Reference ID/Investigator# 44968 — Tübingen, Germany

Full record on ClinicalTrials.gov

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