At a glance
ClinicalIndex Comparison Record- ✓Idiopathic Parkinson's disease meeting United Kingdom Parkinson's Disease Society Brain Bank Criteria
- ✓Levodopa-responsive with severe motor fluctuations
- ✓Documented recognizable off and on state (motor fluctuations) confirmed by diary
- ✕Unclear diagnosis or suspicion of other parkinsonian syndromes such as secondary parkinsonism
- ✕Prior surgery for treatment of PD
- ✕Contraindications to levodopa (such as narrow angle glaucoma)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications
In Brief
A Phase 3 clinical trial evaluating Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, and 2 other interventions for Advanced Parkinson's Disease. Completed, enrolled 354 participants across 83 sites in 16 countries.
Detailed 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.
Study Details
Timeline
Interventions
Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).
percutaneous endoscopic gastrostomy tube
jejunal tube