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NCT00139880 · ClinicalTrials.gov registry record · Phase 3
A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
NCT00139880: Completed Phase 3 study, sponsored by UCB Pharma.
NCT00139880 is a Phase 3 study that has completed, run by UCB Pharma. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00139880, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study Summary
To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of \< 200 mg carbidopa and \< 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.
Interventions
- DRUG Parcopa
Trial Details
| Field | Value |
|---|---|
| Start Date | 2005-06 |
| Est. Completion | 2005-08 |
| Phase | Phase 3 |
What the finished NCT00139880 record still lists
NCT00139880 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 1 intervention - of which Parcopa is the first listed.
NCT00139880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00139880 about?
NCT00139880 is a clinical study titled "A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease". To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having ...
What is the current status of trial NCT00139880?
This trial is currently completed. It is a Phase 3 study. The study started on 2005-06. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00139880?
The interventions under investigation include: Parcopa (DRUG).
Who is sponsoring clinical trial NCT00139880?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
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