Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275457
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2006-01-11
Brief Title:
Efficacy and Safety of Pramipexole PPX in Moderate to Severe Idiopathic Restless Legs Syndrome RLS Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Dose Titration Trial With 0125-075 mg Pramipexole Sifrol Orally to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-label or Double-blind Treatment Period
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:
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension
Detailed Description:
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks open label or double blind extension
Study Hypotheses
Null hypothesis No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment
Comparisons
Pramipexole vs Placebo
Study Hypotheses
Null hypothesis No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment
Comparisons
Pramipexole vs Placebo
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