Clinical trial NCT00219284: Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
Official title: 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 Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease With End of Dose Wearing Off
Keywords: Parkinson's disease, tremor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 359
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 quality of life in patients with Parkinson's disease with end-of-dose wearing off.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change in Parkinson's Disease Quality of Life Score From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment
timeFrame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
measure: Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment
timeFrame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
measure: Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment
timeFrame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Fullerton
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Reseda
country: United States
state: California
city: Stanford
country: United States
state: California
city: Ft. Collins
country: United States
state: Colorado
city: Washington DC
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Palm Beach
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Pompano Beach
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Flossmoor
country: United States
state: Illinois
city: Lenexa
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Bingham Farms
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Hattiesburg
country: United States
state: Mississippi
city: Columbia
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Ridgewood
country: United States
state: New Jersey
city: Commack
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Bellevue
country: United States
state: Ohio
city: Canton
country: United States
state: Ohio
city: Tualatin
country: United States
state: Oregon
city: East Stroudsburg
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Caroline
country: Puerto Rico
Study officials:
References: