Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472199
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2007-05-10
Brief Title:
Long-term Efficacy Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome RLS
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase IV Randomised Double-blind Placebo-controlled Dose Titration Trial With Pramipexole Sifrol Mirapexin 0125-075 mgDay Per os to Investigate the Long-term Efficacy Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-label Extension Treatment Period
Status:
COMPLETED
Status Verified Date:
2012-05
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 primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome RLS in comparison to placebo
The key secondary objectives are to assess the effects on clinical global impressions - global improvement CGI-I based on CGI-I responder rate and on RLS based on IRLS responder rate for 26 weeks under pramipexole in comparison to placebo Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression PGI based on PGI responder rate on RLS symptoms based on the RLS-6 scales on associated mood disturbance based on item 10 of the IRLS on pain in limbs based on a visual analogue scale VAS on quality of life in RLS based on Johns Hopkins RLS-QoL on general quality of life Short Form 36 SF-36 and on safety based on adverse events AE profile of pramipexole in comparison to placebo
The key secondary objectives are to assess the effects on clinical global impressions - global improvement CGI-I based on CGI-I responder rate and on RLS based on IRLS responder rate for 26 weeks under pramipexole in comparison to placebo Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression PGI based on PGI responder rate on RLS symptoms based on the RLS-6 scales on associated mood disturbance based on item 10 of the IRLS on pain in limbs based on a visual analogue scale VAS on quality of life in RLS based on Johns Hopkins RLS-QoL on general quality of life Short Form 36 SF-36 and on safety based on adverse events AE profile of pramipexole in comparison to placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT2006-006431-42 | None | None | None |