Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Attention Deficit Hyperactivity Disorder
Interventions
DRUG

d-Amphetamine Transdermal Patch

"The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period.~Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied."

DRUG

Placebo patch

"The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period.~Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied."

Trial Locations (3)

33199

Florida International University Center for Children and Families, Miami

89128

Center for Psychiatry and Behavioral Medicine Inc., Las Vegas

92612

University of California - Irvine, Irvine

Sponsors
All Listed Sponsors
lead

Noven Pharmaceuticals, Inc.

INDUSTRY