NCT00444574

Brief Summary

Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

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

September 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

March 6, 2007

Last Update Submit

June 23, 2015

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit.

    7 weeks

Secondary Outcomes (2)

  • CTRS-R, CPRS-R, CGI, PGA scores

    7 weeks

  • Treatment emergent AEs, dermal evaluations, PK

    7 weeks

Study Arms (3)

Methylphenidate Transdermal System

ACTIVE COMPARATOR

Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks

Drug: Methylphenidate Transdermal System

Placebo

PLACEBO COMPARATOR

Placebp matching MTS and Concerta for 7 weeks

Drug: Placebo

Concerta

ACTIVE COMPARATOR

Methylphenidate HCL 18mg tablet 7 weeks

Drug: Concerta

Interventions

Methylphenidate Transdermal SystemDRUG

The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA

Also known as: MTS
Methylphenidate Transdermal System
PlaceboDRUG

The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA

Also known as: Sham treatment
Placebo
ConcertaDRUG

The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA

Also known as: Methylphenidate HCL
Concerta

Eligibility Criteria

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

You may qualify if:

  • male or female aged 6-12 years
  • females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.
  • a primary diagnosis of ADHD based on a detailed psychiatric evaluation
  • a total score of =\>26 on the ADHD-RS-IV at the Baseline Visit
  • a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above
  • no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study.

You may not qualify if:

  • a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
  • a known non-responder to psychostimulant treatment
  • overweight (Body Mass Index (BMI)-for-age \>90th percentile)
  • a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
  • Conduct Disorder.
  • Subject has taken an investigational drug within 30 days prior to Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Findling RL, Bukstein OG, Melmed RD, Lopez FA, Sallee FR, Arnold LE, Pratt RD. A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008 Jan;69(1):149-59. doi: 10.4088/jcp.v69n0120.

    PMID: 18312050RESULT

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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 8, 2007

Study Start

September 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

June 25, 2015

Record last verified: 2015-06