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
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: Parcopa (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Patricia Witt, Study Director, Affiliation: UCB
Summary
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.
Clinical Details
Official title: 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 design: Randomized, Double-Blind, Dose Comparison, Crossover Assignment
Detailed description:
See approved Package Insert for Adverse Event information.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Stable Parkinson's disease
Exclusion Criteria:
- idiopathic PD with Hoehn and Yahr state II or III
Locations and Contacts
Schwarz, Milwaukee, Wisconsin, United States
Additional Information
Starting date: June 2005
Ending date: August 2005
Last updated: April 16, 2008
|
