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

Phase 3

Completed

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

• Registration Number: NCT00151983
• Lead Sponsor: Noven Therapeutics

Brief 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.

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-08
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo patch	Methylphenidate Transdermal System	Placebo patch applied daily for 8 weeks
Methylphenidate Transdermal System	Methylphenidate Transdermal System	Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Score on ADHD Rating Scale at 4 weeks	30 days

Secondary Outcome Measures

Name	Time	Method
Parent Global Assessment	30 days
Medication Satisfaction Survey	30 days
Parent rating scale	30 days
ADHD Impact Module	30 days
Clinical Global Impressions Scale	30 days
Adverse events, lab tests, dermal evaluations, ECGs	30 days

Trial Locations

Locations (18)

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

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