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NCT00642356 · ClinicalTrials.gov registry record · Phase 4
Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
A Phase 4 study, sponsored by Novartis.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT00642356: Clinical Trial Phase 4 study, sponsored by Novartis.
NCT00642356 is a Phase 4 study that was terminated before completion, run by Novartis. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00642356, a Phase 4 study, was terminated before completion, sponsored by Novartis.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.
Primary Outcome
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.
Interventions
- DRUG Carbidopa/levodopa/entacapone
- DRUG Immediate release carbidopa/levodopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-05 |
| Phase | Phase 4 |
Why NCT00642356 stopped before completion
NCT00642356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Carbidopa/levodopa/entacapone is the first listed.
NCT00642356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00642356 about?
NCT00642356 is a clinical study titled "Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off". The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.
What is the current status of trial NCT00642356?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2008-03. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00642356?
The interventions under investigation include: Carbidopa/levodopa/entacapone (DRUG), Immediate release carbidopa/levodopa (DRUG).
Who is sponsoring clinical trial NCT00642356?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00642356's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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