NCT00151970

Brief Summary

This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

September 7, 2005

Last Update Submit

July 8, 2015

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • SKAMP deportment rating scale

    Week 8

Secondary Outcomes (7)

  • PERMP age-adjusted math test

    Week 8

  • Clinician-rated ADHD-RS-IV

    Week 8

  • CGI-I

    Week 8

  • Parent Global Assessment

    Week 8

  • Connors' Parent Rating Scale

    Week 8

  • +2 more secondary outcomes

Study Arms (3)

Methylphenidate Transdermal System

ACTIVE COMPARATOR

The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening.

Drug: Methylphenidate Transdermal System

Placebo

PLACEBO COMPARATOR

The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening.

Drug: Placebo

Concerta

ACTIVE COMPARATOR

CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Drug: Concerta

Interventions

Methylphenidate Transdermal SystemDRUG

MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes

Also known as: MTS
Methylphenidate Transdermal System
PlaceboDRUG

Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily

Also known as: Sham Treatment
Placebo
ConcertaDRUG

CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Also known as: Methylphenidate HCL
Concerta

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects have primary diagnosis of ADHD
  • Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
  • Subject has an IQ score of \>\_ 80
  • Subject is able to complete as least the Basic Test of the PERMP assessment

You may not qualify if:

  • Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
  • Subject is taking Strattera(r)
  • Subject has a recent history of suspected substance abuse or dependence disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Wilens TE, Boellner SW, Lopez FA, Turnbow JM, Wigal SB, Childress AC, Abikoff HB, Manos MJ. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):700-708. doi: 10.1097/CHI.0b013e31816bffdf.

    PMID: 18434918BACKGROUND

  • Frazier TW, Weiss M, Hodgkins P, Manos MJ, Landgraf JM, Gibbins C. Time course and predictors of health-related quality of life improvement and medication satisfaction in children diagnosed with attention-deficit/hyperactivity disorder treated with the methylphenidate transdermal system. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):355-64. doi: 10.1089/cap.2009.0092.

    PMID: 20973706DERIVED

  • Manos M, Frazier TW, Landgraf JM, Weiss M, Hodgkins P. HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system. Curr Med Res Opin. 2009 Dec;25(12):3001-10. doi: 10.1185/03007990903388797.

    PMID: 19849639DERIVED

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

June 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

July 9, 2015

Record last verified: 2015-07