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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 o...

Update Il y a 4 ans
Reference: EUCTR2004-002505-74

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

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Extract

To evaluate the safety and tolerability of treatment with Provigil in children and adolescents with excessive sleepiness (ES) associates with narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.

Inclusion criteria

  • Excessive sleepiness associated with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

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