Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139880
Status:
COMPLETED
Last Update Posted:
2013-09-04
First Post:
2005-08-29
Brief Title:
A Single Center Randomized Double-blind Crossover Pilot Trial Comparing the Onset of Action of Parcopa With Sinemet in Subjects With Stable Parkinsons Disease
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Single Center Randomized Double-blind Crossover Pilot Trial Comparing the Onset of Action of Parcopa With Sinemet in Subjects With Stable Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons 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 subjects 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
Detailed Description:
See approved Package Insert for Adverse Event information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None