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”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 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.
• Active Comparator: 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.

Primary Measures

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4
  • Time Frame: Baseline to Week 4
    Safety Issue?: No

Secondary Measures

• Change in Parkinson's Disease Quality of Life Score From Baseline to Week 4
  • Time Frame: Baseline to Week 4
    Safety Issue?: No
• Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8
  • Time Frame: Baseline to Week 8
    Safety Issue?: No
• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8
  • Time Frame: Baseline to Week 8
    Safety Issue?: No
• Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4
  • Time Frame: Baseline to Week 4
    Safety Issue?: No
• Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8
  • Time Frame: Baseline to Week 8
    Safety Issue?: No
• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment
  • Time Frame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
    Safety Issue?: No
• Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment
  • Time Frame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
    Safety Issue?: No
• Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment
  • Time Frame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00219284

Study ID Number: CELC200AUS11

ClinicalTrials.gov Identifier: NCT00219284

Health Authority: United States: Food and Drug Administration