Clinical trial
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel…
NCT00357994 · AbbVie (prior sponsor, Abbott), Industry · Completed
Key facts
| NCT number | NCT00357994 |
|---|---|
| Title | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects |
| Official title | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations |
| Lead sponsor | AbbVie (prior sponsor, Abbott), Industry |
| Collaborators | Quintiles, Inc. Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Advanced Parkinson's Disease |
| Intervention type | Device, Drug |
| Interventions | Levodopa carbidopa intestinal gel (LCIG), Placebo gel, Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets, Placebo (PBO) oral capsules, CADD-Legacy® 1400 ambulatory infusion pump, PEG tube, J-tube |
| Enrollment | 36 |
| Start date | Jan 1, 2009 |
| Primary completion | Oct 1, 2011 |
| Completion | Oct 1, 2011 |
| First posted | Jul 28, 2006 |
| Last update posted | Jan 16, 2015 |
| Countries | Germany, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: