Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

Official Title: “A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy”

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

Intervention(s) in this Clinical Trial

• Drug: Carbidopa/levodopa/entacapone
  • Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.
• Drug: Immediate release carbidopa/levodopa
  • Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Carbidopa/levodopa/entacapone
  • Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
• Active Comparator: Immediate release carbidopa/levodopa
  • Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Primary Measures

• Time to First Occurrence of Dyskinesia
  • Time Frame: Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)
  • Time Frame: Baseline, Week 6 and Week 130
    Safety Issue?: No
• Occurrence of Wearing-off
  • Time Frame: Baseline to Week 134
    Safety Issue?: No
• Time to First Occurrence of Wearing-off
  • Time Frame: Baseline to end of study (134-208 weeks of treatment)
    Safety Issue?: No
• Occurrence of Dyskinesia
  • Time Frame: Baseline to Week 208
    Safety Issue?: No
• Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)
  • Time Frame: Baseline to Week 156
    Safety Issue?: No

Inclusion Criteria:

• Clinical diagnosis of idiopathic Parkinson's disease
• Diagnosis of Parkinson's disease for no more than 5 years

Exclusion Criteria:

• History, signs, or symptoms of atypical or secondary parkinsonism
• Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor complications
• Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1
• Other 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: 70 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/NCT00099268

Study ID Number: CELC200A2401

ClinicalTrials.gov Identifier: NCT00099268

Health Authority: United States: Food and Drug Administration