Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Public ClinicalTrials.gov record NCT00357994. 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
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
Study identification
- NCT ID
- NCT00357994
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Interventions
- Levodopa carbidopa intestinal gel (LCIG) Drug
- Placebo gel Drug
- Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets Drug
- Placebo (PBO) oral capsules 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 2009 (Type not available)
- Primary completion
- Oct 2011 (Actual)
- Completion
- Oct 2011 (Actual)
- Last update posted
- Jan 16, 2015
2009 – 2011
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Reference ID/Investigator# 45719 | Los Angeles | California | 90033 | — |
| Site Reference ID/Investigator# 45718 | Englewood | Colorado | 80113 | — |
| Site Reference ID/Investigator# 45722 | Washington D.C. | District of Columbia | 20007 | — |
| Site Reference ID/Investigator# 45721 | Bradenton | Florida | 34205 | — |
| Site Reference ID/Investigator# 45705 | Gainesville | Florida | 32610 | — |
| Site Reference ID/Investigator# 45740 | Baltimore | Maryland | 21201 | — |
| Site Reference ID/Investigator# 45739 | St Louis | Missouri | 63110 | — |
| Site Reference ID/Investigator# 45703 | Burlington | Vermont | 05401 | — |
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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00357994, 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 NCT00357994 live on ClinicalTrials.gov.