NCT00381758

Brief Summary

This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2002

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
Last Updated

March 10, 2008

Status Verified

March 1, 2008

Enrollment Period

3 months

First QC Date

September 26, 2006

Last Update Submit

March 7, 2008

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDMethylphenidateMetadate CDConcertaCOMACSAttention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (3)

  • School Day Efficacy

  • SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items

  • 1.5 - 7.5 hours post-dosing

Secondary Outcomes (7)

  • SKAMP Attention Items, 1.5-12 hrs;

  • PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;

  • SNAP IV (Swanson Nolan Pelham), day 3 & 7;

  • Treatment Emergent Adverse Events, once weekly;

  • Barkley Symptom scale, once weekly

  • +2 more secondary outcomes

Interventions

Methylphenidate Extended Release CapsulesDRUG

Eligibility Criteria

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

You may qualify if:

  • years of age, inclusive
  • Have a diagnosis of ADHD
  • Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.

You may not qualify if:

  • IQ below 80.
  • The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
  • History of seizures (excluding uncomplicated childhood febrile seizures).
  • Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
  • Comorbid psychiatric diagnosis.
  • Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Simon Hatch

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 28, 2006

Study Start

May 1, 2002

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

March 10, 2008

Record last verified: 2008-03