Clinical Trial Results:
Estudio abierto de 12 meses para la evaluación de la seguridad, la tolerabilidad y la eficacia de armodafinil (150 mg/día y 250 mg/día) como tratamiento para pacientes con somnolencia excesiva asociada a trauma cráneo-cerebral no penetrante leve o moderado- A 12-Month, open-label Study to evaluate the Safety, Tolerability, and Efficacy of Armodafinil (150 and 250 mg/day) as Treatment for Patients with excessive Sleepiness associated with mild or moderte closed Traumatic Brain Injury.
Summary
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EudraCT number |
2009-014544-11 |
Trial protocol |
ES DE |
Global completion date |
31 Jan 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 |
16 Nov 2016
|
First version publication date |
16 Nov 2016
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Other versions |
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Summary report(s) |
C10953-3069-ES-MN SummaryResults.pdf |
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.