Clinical Trial Results:
STEP ONE –trial (Study on the Treatment of Elderly Patients with Older and Newer antiepileptic drugs) - trial:
A multicentre, double-blind, randomized, phase IV clinical trial comparing the safety, tolerability and efficacy of levetiracetam versus lamotrigine and carbamazepine in the oral antiepileptic therapy of newly diagnosed elderly patients with focal epilepsy.
Summary
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EudraCT number |
2005-003324-19 |
Trial protocol |
DE AT |
Global completion date |
31 Aug 2011
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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 |
11 Mar 2020
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First version publication date |
11 Mar 2020
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Other versions |
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Summary report(s) |
STEPONE05_Publication |
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.