Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152958
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2005-09-08
Brief Title:
A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding 6-month Treatment With Open-label Pramipexole Including Titration 0125 025 05 075 mg Orally qn
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Double-blind Placebo-controlled Randomised Withdrawal Study of 3 Month Duration in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding 6-month Treatment With Open-label Pramipexole Including Titration 0125 025 05 075 mg Orally qn
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole
Secondary objectives are the measurement of severity of the RLS assessment of early withdrawal phenomena after termination of trial medication augmentation under treatment sleepiness quality of life and subjective wellbeing the physicians clinical assessment of symptom severity and improvement Another secondary objective is safety and tolerability of treatment
Secondary objectives are the measurement of severity of the RLS assessment of early withdrawal phenomena after termination of trial medication augmentation under treatment sleepiness quality of life and subjective wellbeing the physicians clinical assessment of symptom severity and improvement Another secondary objective is safety and tolerability of treatment
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