A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson’s Disease

Overview

To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.

Full Title of Study: “A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Double
  • Study Primary Completion Date: August 2005

Detailed Description

See approved Package Insert for Adverse Event information.

Interventions

  • Drug: Parcopa

Participating in This Clinical Trial

Inclusion Criteria

  • Stable Parkinson's disease Exclusion Criteria:

  • idiopathic PD with Hoehn and Yahr state II or III

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • UCB Pharma
  • Overall Official(s)
    • UCB Clinical Trial Call Center, Study Director, UCB Pharma

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