drugset / Trial / NCT00214968

Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness

NCT00214968

Phase 3 Completed 92 enrolled Cephalon
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.

Timeline

Start
2005-01
Primary completion
2005-10
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Modafinil Small molecule 400 mg

Indications