Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease
Public ClinicalTrials.gov record NCT00335153. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00335153
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 354 participants
Conditions and interventions
Conditions
Interventions
- Levodopa-carbidopa intestinal gel Drug
- CADD-Legacy® 1400 ambulatory infusion pump Device
- PEG tube Device
- J-tube Device
Drug · Device
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2008 (Type not available)
- Primary completion
- Jun 2012 (Actual)
- Completion
- Jun 2012 (Actual)
- Last update posted
- Jan 16, 2015
2008 – 2012
United States locations
- U.S. sites
- 31
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Reference ID/Investigator# 50065 | Birmingham | Alabama | 35222 | — |
| Site Reference ID/Investigator# 50059 | Fountain Valley | California | 92708 | — |
| Site Reference ID/Investigator# 50048 | Los Angeles | California | 90033 | — |
| Site Reference ID/Investigator# 50076 | Oceanside | California | 92056 | — |
| Site Reference ID/Investigator# 50061 | Englewood | Colorado | 80113 | — |
| Site Reference ID/Investigator# 50079 | Washington D.C. | District of Columbia | 20007 | — |
| Site Reference ID/Investigator# 50077 | Bradenton | Florida | 34205 | — |
| Site Reference ID/Investigator# 50060 | Fort Lauderdale | Florida | 33308 | — |
| Site Reference ID/Investigator# 50049 | Gainesville | Florida | 32610 | — |
| Site Reference ID/Investigator# 50047 | Jacksonville | Florida | 32209 | — |
| Site Reference ID/Investigator# 50068 | Port Charlotte | Florida | 33890 | — |
| Site Reference ID/Investigator# 50046 | Tampa | Florida | 33613 | — |
| Site Reference ID/Investigator# 50062 | Augusta | Georgia | 30912 | — |
| Site Reference ID/Investigator# 50050 | Chicago | Illinois | 60611 | — |
| Site Reference ID/Investigator# 50078 | Chicago | Illinois | 60612 | — |
| Site Reference ID/Investigator# 50064 | Lexington | Kentucky | 40536 | — |
| Site Reference ID/Investigator# 50075 | Shreveport | Louisiana | 71103 | — |
| Site Reference ID/Investigator# 50080 | Baltimore | Maryland | 21201 | — |
| Site Reference ID/Investigator# 50074 | Baltimore | Maryland | 21287 | — |
| Site Reference ID/Investigator# 50073 | St Louis | Missouri | 63110 | — |
| Site Reference ID/Investigator# 50042 | Omaha | Nebraska | 68198-2045 | — |
| Site Reference ID/Investigator# 50072 | Manhasset | New York | 11030 | — |
| Site Reference ID/Investigator# 50067 | New York | New York | 10029 | — |
| Site Reference ID/Investigator# 50066 | New York | New York | 10032 | — |
| Site Reference ID/Investigator# 50069 | Raleigh | North Carolina | 27607 | — |
| Site Reference ID/Investigator# 50063 | Winston-Salem | North Carolina | 27157 | — |
| Site Reference ID/Investigator# 50043 | Cincinnati | Ohio | 45267 | — |
| Site Reference ID/Investigator# 50044 | Cleveland | Ohio | 44195-0001 | — |
| Site Reference ID/Investigator# 50058 | Burlington | Vermont | 05401 | — |
| Site Reference ID/Investigator# 50045 | Kirkland | Washington | 98034 | — |
| Site Reference ID/Investigator# 50070 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 52 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00335153, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 16, 2015 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00335153 live on ClinicalTrials.gov.