Status:
COMPLETED
Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Parkinson's Disease With End of Dose Wearing Off
Eligibility:
All Genders
30-85 years
Phase:
PHASE4
Brief 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.
Detailed Description
This was a prospective, multi-center, randomized, open-label study with blinded raters to evaluate the effects of immediate versus delayed switch to carbidopa/levodopa/entacapone on motor function and...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT00219284
Start Date
January 1 2005
End Date
July 1 2008
Last Update
March 30 2017
Active Locations (42)
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1
Phoenix, Arizona, United States, 85006
2
Fullerton, California, United States, 92835
3
Irvine, California, United States, 92618
4
La Jolla, California, United States, 92037