Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466167
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2007-04-25
Brief Title:
Pivotal Study in Advanced Parkinsons Disease Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Double-blind Double-dummy Placebo-controlled Randomized Three Parallel Groups Study Comparing the Efficacy Safety and Tolerability of Pramipexole Extended Release ER Versus Placebo and Versus Pramipexole Immediate Release IR Administered Orally Over a 26-week Maintenance Phase in L-Dopa Treated Patients With Advanced Parkinsons Disease PD
Status:
COMPLETED
Status Verified Date:
2014-05
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:
The general aim of this trial is to determine the efficacy as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined safety and tolerability of pramipexole ER in daily doses from 0375 milligram to 45 milligram once a day in comparison to placebo in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations
In addition a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done
The efficacy of pramipexole immediate release will also be compared to placebo for assay sensitivity
In addition a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done
The efficacy of pramipexole immediate release will also be compared to placebo for assay sensitivity
Detailed Description:
None
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