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NCT00660673 · ClinicalTrials.gov registry record · Phase 3
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
A Phase 3 study of Advanced Parkinson's Disease, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
- 20
- Study locations
NCT00660673: Completed Phase 3 study of Advanced Parkinson's Disease, sponsored by AbbVie.
NCT00660673 is a Phase 3 study of Advanced Parkinson's Disease that has completed, run by AbbVie. The registered enrollment target is 262 participants, above the 47-participant average among 3 other Advanced Parkinson's Disease trials with a reported enrollment target (457% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00660673, a Phase 3 study of Advanced Parkinson's Disease, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).
Primary Outcome
Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure. At least possibly drug-related is defined as TEAEs assessed as having a "Possible" or "Probable" or missing relationship to study drug. Serious AEs included any untoward medical occurrence that: * Resulted in death * Was life-threatening * Required inpatient hospitalization or prolon
Conditions Studied
Interventions
- DRUG Levodopa-Carbidopa Intestinal Gel (LCIG)
- DEVICE CADD-Legacy® 1400 ambulatory infusion pump
- DEVICE Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)
Study Locations (20)
Florida
- Bradenton Research Center, Inc /ID# 49929 - Bradenton
- Neurologic Consultants, PA /ID# 49918 - Fort Lauderdale
- University of Florida - Archer /ID# 49935 - Gainesville
- University of Florida /ID# 49922 - Jacksonville
- Charlotte Neurological Service /ID# 49916 - Port Charlotte
- University of South Florida /ID# 49919 - Tampa
California
- The Research Center of Southern California /ID# 49928 - Encinitas
- The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915 - Fountain Valley
- Universtiy of Southern California /ID# 49913 - Los Angeles
Illinois
- Northwestern University Feinberg School of Medicine /ID# 49944 - Chicago
- Rush University Medical Center /ID# 49930 - Chicago
Maryland
- Univ Maryland School Medicine /ID# 49934 - Baltimore
- Johns Hopkins University /ID# 49937 - Baltimore
Alabama
- University of Alabama at Birmingham /ID# 49941 - Birmingham
Colorado
- Colorado Neurological Institute /ID# 49927 - Englewood
District of Columbia
- Georgetown University Hospital /ID# 49931 - Washington D.C.
Georgia
- Georgia Regents University /ID# 49938 - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2009-11-13 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 3 |
What the finished NCT00660673 record still lists
NCT00660673 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, above the 47-participant average among 3 other Advanced Parkinson's Disease trials with a reported enrollment target (457% higher).
The record links to 1 condition, with Advanced Parkinson's Disease appearing as the primary indexed condition, and to 3 interventions - of which Levodopa-Carbidopa Intestinal Gel (LCIG) is the first listed.
NCT00660673 names 20 study sites across 11 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT00660673 about?
NCT00660673 is a clinical study titled "Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease". The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).
What is the current status of trial NCT00660673?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2009-11-13. Estimated completion is 2021-11-30.
What conditions does trial NCT00660673 study?
This clinical trial studies the following conditions: Advanced Parkinson's Disease.
What interventions are being tested in trial NCT00660673?
The interventions under investigation include: Levodopa-Carbidopa Intestinal Gel (LCIG) (DRUG), CADD-Legacy® 1400 ambulatory infusion pump (DEVICE), Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J) (DEVICE).
Who is sponsoring clinical trial NCT00660673?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00660673 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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