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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noven Therapeutics
• Treatments: Methylphenidate

Criteria

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