Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
NCT ID: NCT00219284
Last Updated: 2017-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
359 participants
INTERVENTIONAL
2005-01-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate switch
Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.
Delayed switch
Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.
Interventions
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Carbidopa/levodopa/entacapone
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Female subjects who are pregnant, trying to become pregnant or nursing an infant
30 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Fullerton, California, United States
Irvine, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Reseda, California, United States
Stanford, California, United States
Fort Collins, Colorado, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Naples, Florida, United States
Palm Beach, Florida, United States
Plantation, Florida, United States
Pompano Beach, Florida, United States
Port Charlotte, Florida, United States
Chicago, Illinois, United States
Flossmoor, Illinois, United States
Lenexa, Kansas, United States
Topeka, Kansas, United States
Baltimore, Maryland, United States
Bingham Farms, Michigan, United States
Southfield, Michigan, United States
Hattiesburg, Mississippi, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Ridgewood, New Jersey, United States
Commack, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Bellevue, Ohio, United States
Canton, Ohio, United States
Tualatin, Oregon, United States
East Stroudsburg, Pennsylvania, United States
Houston, Texas, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Caroline, , Puerto Rico
Countries
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Other Identifiers
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CELC200AUS11
Identifier Type: -
Identifier Source: org_study_id
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