Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144209
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-09-02
Brief Title:
Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa Benserazide Madopar DR in Patients With Restless Legs Syndrome
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Swiss Restless Legs Syndrome Trial SRLS A Double-blind Randomised Crossover Trial Investigating the Efficacy and Safety of the Dopamine Agonist Pramipexole Sifrol 025-075 mg Per Day Versus Levodopa Benserazide Madopar DR 125-375 mg Per Day in Patients With 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:
The primary objective of this study is to determine that pramipexole Sifrol 025 mg to 075 mg daily is not inferior to levodopa 100 mg to 300 mg in combination with benserazide 25mg to 75mg Madopar DR daily in the treatment of patients with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria The efficacy parameters include an objective measure of the leg movements during the time spent in bed and a quantitative clinical assessment of the severity of RLS in the form of the RLS-score In addition the efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome measures such as quality of life and sleep
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