Clinical Trial Results:
A phase IV randomised, double-blind, placebo-controlled, dose titration trial with 0.125-0.75 mg/day pramipexole (Sifrol/Mirapexin) orally for 12 weeks to investigate the safety and efficacy in out-patients with idiopathic Restless Legs Syndrome associated with mood disturbances
Summary
|
|
EudraCT number |
2005-006128-13 |
Trial protocol |
DE GB IE FI ES SE IT |
Global completion date |
23 Jun 2007
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
16 May 2016
|
First version publication date |
06 May 2015
|
Other versions |
|
Summary report(s) |
248.604 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.