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
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
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.
See approved Package Insert for Adverse Event information.
Inclusion Criteria:

 -  Stable Parkinson's disease

 Exclusion Criteria:

 -  idiopathic PD with Hoehn and Yahr state II or III