Clinical Trial Results:
A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury - Estudio de 12 semanas, aleatorizado, doble-ciego controlado con placebo, de grupos paralelos con dosis fijas para evaluar la eficacia y la seguridad de Armodafinil (50, 150 y 250 mg/día) en el tratamiento de pacientes con somnolencia excesiva asociada a un trauma cráneo-cerebral no penetrante leve o moderado
Summary
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EudraCT number |
2009-014545-83 |
Trial protocol |
ES DE FR CZ |
Global completion date |
06 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
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First version publication date |
16 Nov 2016
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Other versions |
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Summary report(s) |
C10953-3067-ES-MN SummaryResults |
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.