Clinical Trial Results:
A 6 month open-label, flexible-dosage study to assess the safety and effectiveness of PROVIGIL® (Modafinil) treatment in children and adolescents with excessive sleepiness associated with narcolepsy or obstructive sleep apnea/hypopnea.
Summary
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EudraCT number |
2004-002505-74 |
Trial protocol |
CZ FI GB ES IT |
Global completion date |
27 Oct 2005
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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 |
01 Jun 2023
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First version publication date |
01 Jun 2023
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Other versions |
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Summary report(s) |
C1538-3034_CSR_Synopsis_Redacted |
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.