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NCT00099268 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 747
- Enrollment target
NCT00099268: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00099268 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 747 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00099268, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 747 participants
- Enrollment target
Study Summary
The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
Primary Outcome
Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.
Interventions
- DRUG Carbidopa/levodopa/entacapone
- DRUG Immediate release carbidopa/levodopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 747 participants |
| Start Date | 2004-09 |
| Est. Completion | 2008-11 |
| Phase | Phase 3 |
What the finished NCT00099268 record still lists
NCT00099268 is an interventional study that assigns participants to a tested intervention. The registered 747 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Carbidopa/levodopa/entacapone is the first listed.
NCT00099268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00099268 about?
NCT00099268 is a clinical study titled "Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy". The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disea...
What is the current status of trial NCT00099268?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 747 participants. The study started on 2004-09. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00099268?
The interventions under investigation include: Carbidopa/levodopa/entacapone (DRUG), Immediate release carbidopa/levodopa (DRUG).
Who is sponsoring clinical trial NCT00099268?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00099268's enrollment target sits among peer trials
747 472nd of 2000 higher than 1,527 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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