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

Phase 3CompletedNCT00151957

Noven Therapeutics450 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Methylphenidate Transdermal SystemDRUG

MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment emergent adverse events over 12 months.

Time frame: Weekly

Secondary Outcomes

ADHD-RS-IV scores

Time frame: Weekly

Parent Global Assessment

Time frame: Weekly

Clinical Global Impressions Scale

Time frame: Weekly

Child's Sleep Habits Questionnaire

Time frame: Weekly

Data from ClinicalTrials.gov

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