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NCT00219284 · ClinicalTrials.gov registry record · Phase 4

Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease

A Phase 4 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
359
Enrollment target

NCT00219284: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.

NCT00219284 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 359 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00219284, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
359 participants
Enrollment target

Study Summary

To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone.

Primary Outcome

Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.

Interventions

  • DRUG Carbidopa/levodopa/entacapone

Trial Details

FieldValue
Enrollment Target 359 participants
Start Date 2005-01
Est. Completion 2008-07
Phase Phase 4
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00219284 record still lists

NCT00219284 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower).

The record links to 0 conditions, and to 1 intervention - of which Carbidopa/levodopa/entacapone is the first listed.

NCT00219284 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00219284 about?

NCT00219284 is a clinical study titled "Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease". To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone.

What is the current status of trial NCT00219284?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 359 participants. The study started on 2005-01. Estimated completion is 2008-07.

What interventions are being tested in trial NCT00219284?

The interventions under investigation include: Carbidopa/levodopa/entacapone (DRUG).

Who is sponsoring clinical trial NCT00219284?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00219284's enrollment target sits among peer trials

359 226th of 2000 higher than 1,775 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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Source: ClinicalTrials.gov NCT00219284, the US trial registry maintained by the National Library of Medicine. NCT00219284 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.