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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

September 30, 2015

Study Completion Date

December 31, 2015

Conditions
Narcolepsy
Interventions
DRUG

Armodafinil

The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.

Trial Locations (24)

Unknown

Teva Investigational Site 12, Birmingham

Teva Investigational Site 17, Birmingham

Teva Investigational Site 7, Little Rock

Teva Investigational Site 18, Orange

Teva Investigational Site 16, San Diego

Teva Investigational Site 4, Stanford

Teva Investigational Site 9, Clearwater

Teva Investigational Site 26, Miami Lakes

Teva Investigational Site 5, Spring Hill

Teva Investigational Site 25, Winter Park

Teva Investigational Site 1, Atlanta

Teva Investigational Site 2, Atlanta

Teva Investigational Site 20, Louisville

Teva Investigational Site 15, Grand Blanc

Teva Investigational Site 3, West Seneca

Teva Investigational Site 23, Raleigh

Teva Investigational Site 10, Toledo

Teva Investigational Site 13, Oklahoma City

Teva Investigational Site 19, West Chester

Teva Investigational Site 8, Houston

Teva Investigational Site 14, San Antonio

Teva Investigational Site 27, Everett

Teva Investigational Site 24, Seattle

Teva Investigational Site 200, Helsinki

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT01624480 - Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy | Biotech Hunter | Biotech Hunter