Clinical Trial Results:
A Phase III double-blind, double-dummy, placebo-controlled, 8 week fixed dose trial with pramipexole IR (Mirapex®, Mirapexin®, Pexola®, Sifrol®) 0.125 and 0.5 mg/day administered orally to investigate the efficacy and safety in patients 6-17 years of age diagnosed with Tourette Syndrome according to DSM-IV criteria
Summary
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EudraCT number |
2008-000343-33 |
Trial protocol |
DE |
Global completion date |
07 Aug 2009
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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 |
This version publication date |
07 Jul 2018
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First version publication date |
07 Jul 2018
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Other versions |
v2 |
Summary report(s) |
Statement |
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.