Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

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

Details

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

Criteria

Inclusion Criteria:

• Subject must have a primary diagnosis of ADHD

• Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day

• Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test

Exclusion Criteria:

• A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually

• A recent history of suspected substance abuse or dependence disorder

• Subject is taking Strattera

• Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites