Clinical Trial Results:
A phase IV randomised, double-blind, placebo-controlled, dose titration trial with pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/day per os to investigate the long-term efficacy, safety and tolerability in patients with idiopathic moderate to severe Restless Legs Syndrome for 26 weeks
Summary
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EudraCT number |
2006-006431-42 |
Trial protocol |
DE SK FI IE BE AT GR GB ES |
Global completion date |
03 Jul 2008
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
16 May 2016
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First version publication date |
06 May 2015
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Other versions |
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Summary report(s) |
248.629 |
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.