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Safety and Tolerability of Daytrana in Children with ADHD
NCT00151983Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2005
- Primary completion
- Jul 2006
- Countries
- 1
- Sponsor
- Noven Therapeutics, LLC
- Modality
- Small Molecules
- Conditions
- attention deficit hyperactivity disorder (ADHD)
01
Overview
Phase 3, open-label, single-arm trial of methylphenidate transdermal system in attention deficit hyperactivity disorder (ADHD), sponsored by Noven Therapeutics, LLC. Primary endpoint: ADHD Rating Scale-IV at 4 weeks. Started Jun 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Methylphenidate Transdermal System
Daytrana patch applied daily.
03
Who it enrols
Children aged 6-12 with a primary diagnosis of ADHD who are adequately controlled on a stable dose of Ritalin LA, Concerta, or Metadate CD. Patients with skin irritation or taking Strattera are excluded.
04
Endpoints
Primary
ADHD Rating Scale-IV
Secondary
Parent Rating Scale
Parent Global Assessment
Medication Satisfaction Survey
ADHD Impact Module
Clinical Global Impressions Scale
Adverse Events
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