Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
Phase 2
Completed
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Registration Number
- NCT00151970
- Lead Sponsor
- Noven Therapeutics
- Brief Summary
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
- Detailed Description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
- Subjects have primary diagnosis of ADHD
- Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
- Subject has an IQ score of >_ 80
- Subject is able to complete as least the Basic Test of the PERMP assessment
Exclusion Criteria
- Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
- Subject is taking Strattera(r)
- Subject has a recent history of suspected substance abuse or dependence disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Methylphenidate Transdermal System Methylphenidate Transdermal System The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening. Placebo Placebo The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening. Concerta Concerta CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
- Primary Outcome Measures
Name Time Method SKAMP deportment rating scale Week 8
- Secondary Outcome Measures
Name Time Method Clinician-rated ADHD-RS-IV Week 8 SKAMP-total and inattention subscales Week 8 Parent Global Assessment Week 8 ADHD Impact Module-Children Week 8 PERMP age-adjusted math test Week 8 CGI-I Week 8 Connors' Parent Rating Scale Week 8