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NCT00357994 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
A Phase 3 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 3
- Development phase
- 36
- Enrollment target
NCT00357994: Completed Phase 3 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT00357994 is a Phase 3 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 36 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00357994, a Phase 3 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 36 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the an
Interventions
- DRUG Placebo gel
- DEVICE CADD-Legacy® 1400 ambulatory infusion pump
- DRUG Levodopa carbidopa intestinal gel (LCIG)
- DRUG Placebo (PBO) oral capsules
- DRUG Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT00357994 record still lists
NCT00357994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo gel is the first listed.
NCT00357994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00357994 about?
NCT00357994 is a clinical study titled "Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects". 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.
What is the current status of trial NCT00357994?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 36 participants. The study started on 2009-01. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00357994?
The interventions under investigation include: Placebo gel (DRUG), CADD-Legacy® 1400 ambulatory infusion pump (DEVICE), Levodopa carbidopa intestinal gel (LCIG) (DRUG), Placebo (PBO) oral capsules (DRUG), Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets (DRUG).
Who is sponsoring clinical trial NCT00357994?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00357994's enrollment target sits among peer trials
36 1901st of 2000 higher than 98 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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