Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-27 @ 5:58 AM
Study NCT ID:
NCT00466167
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2007-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pivotal Study in Advanced Parkinsons Disease Patients
Sponsor:
Boehringer Ingelheim
Organization:
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 0.375 milligram to 4.5 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: