NCT01711021

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

A Randomized, Double-Blind, Placebo-Controlled, Crossover, Laboratory Classroom Study to Evaluate the Safety and Efficacy of d-Amphetamine Transdermal Drug Delivery System (d-ATS) Compared to Placebo in Children and Adolescents With ADHD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Noven Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.

Detailed description

The study will consist of a four-week screening period, a 3-day wash-out period (if applicable), a five-week open-label, step-wise dose optimization period and two-week double blind randomized crossover treatment period with weekly classroom assessments and a safety follow-up by telephone 7 - 10 days after last dose of study drug.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-10-22
• Last updated: 2023-12-21
• Results posted: 2023-12-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study