Melanoma Clinical Trial

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

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 advanced Parkinson's disease (PD) and severe motor fluctuations.

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Full 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 antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (NJ) tube placement.
NJ Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of NJ tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via NJ tube and infusion pump (participant was hospitalized for NJ tube placement but hospitalization was not required for entire duration of LCIG treatment optimization).
PEG-J Period (2 to 14 days): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.
Post PEG-J Long-Term Treatment Period (Day 28 to Day 378): LCIG administration via a permanent PEG-J tube and infusion pump, with dosage adjusted according to clinical condition.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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)

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

354

Study ID:

NCT00335153

Recruitment Status:

Completed

Sponsor:

AbbVie (prior sponsor, Abbott)

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There are 83 Locations for this study

See Locations Near You

Site Reference ID/Investigator# 50065
Birmingham Alabama, 35222, United States
Site Reference ID/Investigator# 50059
Fountain Valley California, 92708, United States
Site Reference ID/Investigator# 50048
Los Angeles California, 90033, United States
Site Reference ID/Investigator# 50076
Oceanside California, 92056, United States
Site Reference ID/Investigator# 50061
Englewood Colorado, 80113, United States
Site Reference ID/Investigator# 50079
Washington District of Columbia, 20007, United States
Site Reference ID/Investigator# 50077
Bradenton Florida, 34205, United States
Site Reference ID/Investigator# 50060
Fort Lauderdale Florida, 33308, United States
Site Reference ID/Investigator# 50049
Gainesville Florida, 32610, United States
Site Reference ID/Investigator# 50047
Jacksonville Florida, 32209, United States
Site Reference ID/Investigator# 50068
Port Charlotte Florida, 33890, United States
Site Reference ID/Investigator# 50046
Tampa Florida, 33613, United States
Site Reference ID/Investigator# 50062
Augusta Georgia, 30912, United States
Site Reference ID/Investigator# 50050
Chicago Illinois, 60611, United States
Site Reference ID/Investigator# 50078
Chicago Illinois, 60612, United States
Site Reference ID/Investigator# 50064
Lexington Kentucky, 40536, United States
Site Reference ID/Investigator# 50075
Shreveport Louisiana, 71103, United States
Site Reference ID/Investigator# 50080
Baltimore Maryland, 21201, United States
Site Reference ID/Investigator# 50074
Baltimore Maryland, 21287, United States
Site Reference ID/Investigator# 50073
St. Louis Missouri, 63110, United States
Site Reference ID/Investigator# 50042
Omaha Nebraska, 68198, United States
Site Reference ID/Investigator# 50072
Manhasset New York, 11030, United States
Site Reference ID/Investigator# 50067
New York New York, 10029, United States
Site Reference ID/Investigator# 50066
New York New York, 10032, United States
Site Reference ID/Investigator# 50069
Raleigh North Carolina, 27607, United States
Site Reference ID/Investigator# 50063
Winston-Salem North Carolina, 27157, United States
Site Reference ID/Investigator# 50043
Cincinnati Ohio, 45267, United States
Site Reference ID/Investigator# 50044
Cleveland Ohio, 44195, United States
Site Reference ID/Investigator# 50058
Burlington Vermont, 05401, United States
Site Reference ID/Investigator# 50045
Kirkland Washington, 98034, United States
Site Reference ID/Investigator# 50070
Milwaukee Wisconsin, 53226, United States
Site Reference ID/Investigator# 46429
Adelaide , 5000, Australia
Site Reference ID/Investigator# 46427
Heidelberg , 3084, Australia
Site Reference ID/Investigator# 46425
Westmead , 2145, Australia
Site Reference ID/Investigator# 54545
Edmonton , T6G 2, Canada
Site Reference ID/Investigator# 46433
Montreal , H2L 4, Canada
Site Reference ID/Investigator# 46434
Toronto , M5T 2, Canada
Site Reference ID/Investigator# 46436
Brno , 65691, Czech Republic
Site Reference ID/Investigator# 46438
Hradec Kralove , 500 0, Czech Republic
Site Reference ID/Investigator# 46435
Pardubice , 532 0, Czech Republic
Site Reference ID/Investigator# 46437
Prague 2 , 128 0, Czech Republic
Site Reference ID/Investigator# 46439
Prague 5 , 15006, Czech Republic
Site Reference ID/Investigator# 48003
Lahti , 15850, Finland
Site Reference ID/Investigator# 48028
Berlin , 12200, Germany
Site Reference ID/Investigator# 48029
Berlin , 13088, Germany
Site Reference ID/Investigator# 48036
Freiburg , 79106, Germany
Site Reference ID/Investigator# 48034
Goettingen , 37075, Germany
Site Reference ID/Investigator# 48022
Hanau , 63450, Germany
Site Reference ID/Investigator# 48024
Hanover , 30625, Germany
Site Reference ID/Investigator# 48035
Mainz , 55131, Germany
Site Reference ID/Investigator# 49882
Tel Aviv , 64239, Israel
Site Reference ID/Investigator# 50131
Arcugnano , 36057, Italy
Site Reference ID/Investigator# 50132
Catania , 95125, Italy
Site Reference ID/Investigator# 50128
Genoa , 16132, Italy
Site Reference ID/Investigator# 50129
Lido di Camaiore , 55043, Italy
Site Reference ID/Investigator# 50130
Naples , 80131, Italy
Site Reference ID/Investigator# 50127
Rome , 00163, Italy
Site Reference ID/Investigator# 50138
Nijmegen , 6532 , Netherlands
Site Reference ID/Investigator# 50126
Auckland , 1010, New Zealand
Site Reference ID/Investigator# 50123
Christchurch , 8011, New Zealand
Site Reference ID/Investigator# 50124
Hamilton , 3204, New Zealand
Site Reference ID/Investigator# 50125
Wellington , 6002, New Zealand
Site Reference ID/Investigator# 50140
Lodz , 93-11, Poland
Site Reference ID/Investigator# 50139
Poznan , 61-48, Poland
Site Reference ID/Investigator# 50136
Almada , 2805-, Portugal
Site Reference ID/Investigator# 50134
Coimbra , 3000-, Portugal
Site Reference ID/Investigator# 50135
Lisbon , 1649-, Portugal
Site Reference ID/Investigator# 50137
Porto , 4200-, Portugal
Site Reference ID/Investigator# 50143
Kazan , 42006, Russian Federation
Site Reference ID/Investigator# 50141
Moscow , 12536, Russian Federation
Site Reference ID/Investigator# 50145
St. Petersburg , 19331, Russian Federation
Site Reference ID/Investigator# 50142
St. Petersburg , 19404, Russian Federation
Site Reference ID/Investigator# 50147
St. Petersburg , 19708, Russian Federation
Site Reference ID/Investigator# 50146
St. Petersburg , 19770, Russian Federation
Site Reference ID/Investigator# 50154
Barcelona , 08003, Spain
Site Reference ID/Investigator# 50152
Barcelona , 08025, Spain
Site Reference ID/Investigator# 50202
Barcelona , 08035, Spain
Site Reference ID/Investigator# 50155
Barcelona , 08036, Spain
Site Reference ID/Investigator# 50153
Madrid , 28034, Spain
Site Reference ID/Investigator# 50150
Bangkok , 10330, Thailand
Site Reference ID/Investigator# 50151
Bangkok , 10700, Thailand
Site Reference ID/Investigator# 50149
Liverpool , L9 7L, United Kingdom
Site Reference ID/Investigator# 50148
London , WC1N , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

354

Study ID:

NCT00335153

Recruitment Status:

Completed

Sponsor:


AbbVie (prior sponsor, Abbott)

How clear is this clinincal trial information?

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