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

Information source: Noven Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: Methylphenidate Transdermal System (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Noven Therapeutics

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.

Clinical Details

Official title: A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Score on ADHD Rating Scale at 4 weeks

Secondary outcome:

Parent rating scale

Parent Global Assessment

Medication Satisfaction Survey

ADHD Impact Module

Clinical Global Impressions Scale

Adverse events, lab tests, dermal evaluations, ECGs

Detailed description: Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

Eligibility

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

Meadowbrook Research, Inc., Scottsdale, Arizona, United States

Psychiatric Centers at San Diego, San Marcos, California, United States

Alpine Clinical Research Center, Boulder, Colorado, United States

Miami Research Associates, Inc., Miami, Florida, United States

Capstone Clinical Research, Libertyville, Illinois, United States

Pedia Research, LLC, Owensboro, Kentucky, United States

ProMed Pediatrics, Kalamazoo, Michigan, United States

Children's Specialized Hospital, Toms River, New Jersey, United States

North Carolina Neuropsychiatry PA, Chapel Hill, North Carolina, United States

Ohio State University, Columbus, Ohio, United States

IPS Research Company, Oklahoma City, Oklahoma, United States

Oregon Center for Clinical Investigations (OCCI, Inc.), Portland, Oregon, United States

CNS Research Institute, Philadelphia, Pennsylvania, United States

Western Psychiatric Institute & Clinic, Pittsburgh, Pennsylvania, United States

Claghorn-Lesem Research Clinic, Bellaire, Texas, United States

ADHD Clinic of San Antonio, San Antonio, Texas, United States

NeuroScience, Inc., Herndon, Virginia, United States

Monarch Medical Research, Norfolk, Virginia, United States

Additional Information

Starting date: June 2005
Last updated: July 8, 2015

Page last updated: August 23, 2015

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