Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact
NCT ID: NCT00141518
Last Updated: 2016-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
77 participants
INTERVENTIONAL
2006-03-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Duodopa Naïve
Duodopa-naïve participants titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.
Levodopa-carbidopa intestinal gel (LCIG)
CADD-Legacy® 1400 ambulatory infusion pump
percutaneous endoscopic gastrostomy tube (PEG tube)
jejunal extension tube (J-tube)
Duodopa Non-naïve < 2 Years
Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.
Levodopa-carbidopa intestinal gel (LCIG)
CADD-Legacy® 1400 ambulatory infusion pump
percutaneous endoscopic gastrostomy tube (PEG tube)
jejunal extension tube (J-tube)
Duodopa Non-naïve ≥ 2 years
Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.
Levodopa-carbidopa intestinal gel (LCIG)
CADD-Legacy® 1400 ambulatory infusion pump
percutaneous endoscopic gastrostomy tube (PEG tube)
jejunal extension tube (J-tube)
Interventions
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Levodopa-carbidopa intestinal gel (LCIG)
CADD-Legacy® 1400 ambulatory infusion pump
percutaneous endoscopic gastrostomy tube (PEG tube)
jejunal extension tube (J-tube)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Bergmann, MD
Role: STUDY_DIRECTOR
AbbVie
Related Links
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Related Info
Other Identifiers
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2005-002654-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S187.4.001
Identifier Type: -
Identifier Source: org_study_id
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