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

NCT00151983 — Phase 3, Completed, 175 participants, Noven Therapeutics
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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.

RegistryNCT00151983
StatusCompleted
PhasePhase 3
Study typeInterventional; na, single group, masking: none, treatment
Enrollment175 (Actual)
SponsorNoven Therapeutics (Industry); collaborators: Noven Pharmaceuticals, Inc.
ConditionsAttention Deficit Disorder With Hyperactivity
InterventionsMethylphenidate Transdermal System (Drug)
Datesstart 2005-06-01, primary completion 2006-07-01, completion 2006-07-01, first posted 2005-09-09, last updated 2015-07-09
Locations18 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Attention Deficit Disorder With Hyperactivity All trials of Methylphenidate Transdermal System

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Methylphenidate Transdermal SystemActive comparatorDrug: Methylphenidate Transdermal SystemMethylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
Placebo patchPlacebo comparatorDrug: Methylphenidate Transdermal SystemPlacebo patch applied daily for 8 weeks
  • Methylphenidate Transdermal System (Drug), also known as MTS: To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo

+Outcome measures

Primary outcomes

  • Score on ADHD Rating Scale at 4 weeks [30 days]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 6 Years to 12 Years

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 (18)

FacilityCityCountryStatus
Meadowbrook Research, Inc.Scottsdale, ArizonaUnited States
Psychiatric Centers at San DiegoSan Marcos, CaliforniaUnited States
Alpine Clinical Research CenterBoulder, ColoradoUnited States
Miami Research Associates, Inc.Miami, FloridaUnited States
Capstone Clinical ResearchLibertyville, IllinoisUnited States
Pedia Research, LLCOwensboro, KentuckyUnited States
ProMed PediatricsKalamazoo, MichiganUnited States
Children's Specialized HospitalToms River, New JerseyUnited States
North Carolina Neuropsychiatry PAChapel Hill, North CarolinaUnited States
Ohio State UniversityColumbus, OhioUnited States
IPS Research CompanyOklahoma City, OklahomaUnited States
Oregon Center for Clinical Investigations (OCCI, Inc.)Portland, OregonUnited States
CNS Research InstitutePhiladelphia, PennsylvaniaUnited States
Western Psychiatric Institute & ClinicPittsburgh, PennsylvaniaUnited States
Claghorn-Lesem Research ClinicBellaire, TexasUnited States
ADHD Clinic of San AntonioSan Antonio, TexasUnited States
NeuroScience, Inc.Herndon, VirginiaUnited States
Monarch Medical ResearchNorfolk, VirginiaUnited States

+Publications

  • Results publication: Bukstein OG, Arnold LE, Landgraf JM, Hodgkins P. Does switching from oral extended-release methylphenidate to the methylphenidate transdermal system affect health-related quality-of-life and medication satisfaction for children with attention-deficit/hyperactivity disorder? Child Adolesc Psychiatry Ment Health. 2009 Dec 10;3(1):39. doi: 10.1186/1753-2000-3-39. PMID 20003260
  • Results publication: Arnold LE, Bozzolo DR, Hodgkins P, McKay M, Beckett-Thurman L, Greenbaum M, Bukstein O, Patel A. Switching from oral extended-release methylphenidate to the methylphenidate transdermal system: continued attention-deficit/hyperactivity disorder symptom control and tolerability after abrupt conversion. Curr Med Res Opin. 2010 Jan;26(1):129-37. doi: 10.1185/03007990903437412. PMID 19916704