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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Noven Therapeutics
• Collaborator: Noven Pharmaceuticals, Inc.
• Treatments: Methylphenidate

Criteria

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