Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD

Noven Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Methylphenidate Transdermal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00466791

SPD485-201

Details and patient eligibility

About

Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD

Full description

Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD

Enrollment: 93 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis ADHD
• Total score of greater than or equal to 26 on ADHD-RS-IV
• IQ of greater than or equal to 80
• Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline

Exclusion criteria

• Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
• Known nonresponder to psychostimulant treatment
• BMI for age greater than 90th percentile
• History of seizures during last 2 years
• Conduct Disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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93 participants in 2 patient groups, including a placebo group

Methylphenidate Transdermal System

Active Comparator group

Description:

Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks

Treatment:

Drug: Methylphenidate Transdermal System

Placebo

Placebo Comparator group

Description:

Transdermal patch, 0mg, daily for 11 weeks

Treatment:

Drug: Methylphenidate Transdermal System