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

Completed · Phase 4

Conditions studied: Parkinson's Disease With End of Dose Wearing Off

In brief

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.

Key facts

Study ID

NCT00219284

Run by

Novartis Pharmaceuticals

People needed

359

Starts

2005-01-01

Expected to finish

2008-07-01

Last updated by the study team

2017-03-30

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females 30-80 years of age (inclusive). Patients aged 81-85 years were eligible to participate if the principal investigator considered the patient to be in otherwise good health.
• Clinical diagnosis of Parkinson's disease exhibiting two of three symptoms (rigidity, resting tremor, bradykinesia).
• All patients were required to have end-of dose wearing off (EODWO, re-emergence of PD symptoms at the end of at least two daily doses of levodopa during waking hours).
• Taking regular doses of immediate release carbidopa/levodopa

You may not qualify if…

• Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose regimens of levodopa
• Female subjects who are pregnant, trying to become pregnant or nursing an infant
• Other protocol-defined inclusion/exclusion criteria applied to this study.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Fullerton, California, United States
• Study site — Irvine, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — Reseda, California, United States
• Study site — Stanford, California, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Boca Raton, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Palm Beach, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Pompano Beach, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Flossmoor, Illinois, United States
• Study site — Lenexa, Kansas, United States
• Study site — Topeka, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Bingham Farms, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.