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.
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.
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)
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There are 83 Locations for this study
Birmingham Alabama, 35222, United States
Fountain Valley California, 92708, United States
Los Angeles California, 90033, United States
Oceanside California, 92056, United States
Englewood Colorado, 80113, United States
Washington District of Columbia, 20007, United States
Bradenton Florida, 34205, United States
Fort Lauderdale Florida, 33308, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32209, United States
Port Charlotte Florida, 33890, United States
Tampa Florida, 33613, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Lexington Kentucky, 40536, United States
Shreveport Louisiana, 71103, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
St. Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Manhasset New York, 11030, United States
New York New York, 10029, United States
New York New York, 10032, United States
Raleigh North Carolina, 27607, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Burlington Vermont, 05401, United States
Kirkland Washington, 98034, United States
Milwaukee Wisconsin, 53226, United States
Adelaide , 5000, Australia
Heidelberg , 3084, Australia
Westmead , 2145, Australia
Edmonton , T6G 2, Canada
Montreal , H2L 4, Canada
Toronto , M5T 2, Canada
Brno , 65691, Czech Republic
Hradec Kralove , 500 0, Czech Republic
Pardubice , 532 0, Czech Republic
Prague 2 , 128 0, Czech Republic
Prague 5 , 15006, Czech Republic
Lahti , 15850, Finland
Berlin , 12200, Germany
Berlin , 13088, Germany
Freiburg , 79106, Germany
Goettingen , 37075, Germany
Hanau , 63450, Germany
Hanover , 30625, Germany
Mainz , 55131, Germany
Tel Aviv , 64239, Israel
Arcugnano , 36057, Italy
Catania , 95125, Italy
Genoa , 16132, Italy
Lido di Camaiore , 55043, Italy
Naples , 80131, Italy
Rome , 00163, Italy
Nijmegen , 6532 , Netherlands
Auckland , 1010, New Zealand
Christchurch , 8011, New Zealand
Hamilton , 3204, New Zealand
Wellington , 6002, New Zealand
Lodz , 93-11, Poland
Poznan , 61-48, Poland
Almada , 2805-, Portugal
Coimbra , 3000-, Portugal
Lisbon , 1649-, Portugal
Porto , 4200-, Portugal
Kazan , 42006, Russian Federation
Moscow , 12536, Russian Federation
St. Petersburg , 19331, Russian Federation
St. Petersburg , 19404, Russian Federation
St. Petersburg , 19708, Russian Federation
St. Petersburg , 19770, Russian Federation
Barcelona , 08003, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28034, Spain
Bangkok , 10330, Thailand
Bangkok , 10700, Thailand
Liverpool , L9 7L, United Kingdom
London , WC1N , United Kingdom
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