A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Noven Therapeutics0 sites450 target enrollmentOctober 2004

ConditionsAttention Deficit Disorder With Hyperactivity

InterventionsMethylphenidate Transdermal System

DrugsMethylphenidate Transdermal System

Overview

Phase: Phase 3
Intervention: Methylphenidate Transdermal System
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Noven Therapeutics
Enrollment: 450
Primary Endpoint: Treatment emergent adverse events over 12 months.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Detailed Description

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

June 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Noven Therapeutics

Responsible Party

Sponsor

Eligibility 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-
•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