drugset
drugset / Trial / NCT01624480

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

NCT01624480 ↗

Phase 1 Completed 40 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.

Timeline

Start
2012-07
Primary completion
2015-09
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Armodafinil Small molecule 50 mg —
Subject Armodafinil Small molecule 100 mg —
Subject Armodafinil Small molecule 150 mg —

Indications

narcolepsy