Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375284
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2006-09-11
Brief Title:
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 025 mg Pramipexole Mirapex in Patients With RLS
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase IV Randomised Double-blind Active and Placebo-controlled 6-week Trial to Investigate the Efficacy and Safety of a Starting and Fixed Dose 025 mg Pramipexole Mirapex in Patients With Idiopathic Restless Legs Syndrome
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This trial is a 6-week double-blind randomized active and placebo-controlled parallel-group study with a primary objective of comparison of starting doses of pramipexole fixed-dose 025 mg daily and pramipexole titrated-dose 0125 mg qd for 1 week then 025 mg qd for the remaining 5 weeks with placebo to evaluate efficacy and safety in treating RLS symptoms in patients diagnosed with idiopathic RLS
The secondary objectives of this study will be to assess the onset of action of symptomatic relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two intervals of the first 2 weeks Days 2 3 and 4 and Days 9 10 and 11 and assessment of IRLS PGI and CGI-I at Weeks 1 2 4 and 6 CGI-I additionally on Day 3
The secondary objectives of this study will be to assess the onset of action of symptomatic relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two intervals of the first 2 weeks Days 2 3 and 4 and Days 9 10 and 11 and assessment of IRLS PGI and CGI-I at Weeks 1 2 4 and 6 CGI-I additionally on Day 3
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