Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

Noven Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Placebo; Drug: Methylphenidate Transdermal System; Drug: Concerta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151970

SPD485-304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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128 participants in 3 patient groups, including a placebo group

Methylphenidate Transdermal System

Active Comparator group

Description:

The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening.

Treatment:

Drug: Methylphenidate Transdermal System

Placebo

Placebo Comparator group

Description:

The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening.

Treatment:

Drug: Placebo

Concerta

Active Comparator group

Description:

CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Treatment:

Drug: Concerta