Status:
COMPLETED
Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Advanced Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
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 adv...
Detailed Description
The study was composed of a screening period followed by 3 sequential on-treatment periods, as follows: * Screening Period (up to 28 days): determination of eligibility and discontinuation of antipar...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT00335153
Start Date
January 1 2008
End Date
June 1 2012
Last Update
January 16 2015
Active Locations (83)
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1
Site Reference ID/Investigator# 50065
Birmingham, Alabama, United States, 35222
2
Site Reference ID/Investigator# 50059
Fountain Valley, California, United States, 92708
3
Site Reference ID/Investigator# 50048
Los Angeles, California, United States, 90033
4
Site Reference ID/Investigator# 50076
Oceanside, California, United States, 92056