Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.

• Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.

Exclusion Criteria:

• Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols

• Female subject is pregnant or lactating