Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

Completed · Phase 3

Conditions studied: Advanced Parkinson's Disease

In brief

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

Key facts

Study ID

NCT00335153

Run by

AbbVie (prior sponsor, Abbott)

People needed

354

Starts

2008-01-01

Expected to finish

2012-06-01

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 with severe motor fluctuations
• Recognizable off and on state (motor fluctuations) confirmed by diary

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 (such as narrow angle glaucoma)

Where it is running

• Site Reference ID/Investigator# 50059 — Fountain Valley, California, United States
• Site Reference ID/Investigator# 50048 — Los Angeles, California, United States
• Site Reference ID/Investigator# 50076 — Oceanside, California, United States
• Site Reference ID/Investigator# 50061 — Englewood, Colorado, United States
• Site Reference ID/Investigator# 50079 — Washington D.C., District of Columbia, United States
• Site Reference ID/Investigator# 50077 — Bradenton, Florida, United States
• Site Reference ID/Investigator# 50060 — Fort Lauderdale, Florida, United States
• Site Reference ID/Investigator# 50049 — Gainesville, Florida, United States
• Site Reference ID/Investigator# 50047 — Jacksonville, Florida, United States
• Site Reference ID/Investigator# 50068 — Port Charlotte, Florida, United States
• Site Reference ID/Investigator# 50046 — Tampa, Florida, United States
• Site Reference ID/Investigator# 50062 — Augusta, Georgia, United States
• Site Reference ID/Investigator# 50050 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 50078 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 50064 — Lexington, Kentucky, United States
• Site Reference ID/Investigator# 50075 — Shreveport, Louisiana, United States
• Site Reference ID/Investigator# 50080 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 50074 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 50073 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 50042 — Omaha, Nebraska, United States
• Site Reference ID/Investigator# 50072 — Manhasset, New York, United States
• Site Reference ID/Investigator# 50067 — New York, New York, United States
• Site Reference ID/Investigator# 50066 — New York, New York, United States
• Site Reference ID/Investigator# 50069 — Raleigh, North Carolina, United States
• Site Reference ID/Investigator# 50065 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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