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

Phase 3

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: Methylphenidate Transdermal System

• Registration Number: NCT00151957
• Lead Sponsor: Noven Therapeutics

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

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methylphenidate transdermal system	Methylphenidate Transdermal System	MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events over 12 months.	Weekly

Secondary Outcome Measures

Name	Time	Method
ADHD-RS-IV scores	Weekly
Parent Global Assessment	Weekly
Clinical Global Impressions Scale	Weekly
Child's Sleep Habits Questionnaire	Weekly