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

March 27, 2017 updated by: Noven Therapeutics

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Methylphenidate transdermal system
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Drug: Methylphenidate Transdermal System
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Other Names:
  • MTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment emergent adverse events over 12 months.
Time Frame: Weekly
Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
ADHD-RS-IV scores
Time Frame: Weekly
Weekly
Parent Global Assessment
Time Frame: Weekly
Weekly
Clinical Global Impressions Scale
Time Frame: Weekly
Weekly
Child's Sleep Habits Questionnaire
Time Frame: Weekly
Weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noven Therapeutics

Collaborators

Noven Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (ESTIMATE)

September 9, 2005

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD485-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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