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CompletedNCT00518232Updated Apr 28, 2010

A Study to Determine Effective and Tolerable Titration Scheme for OROS-Methylphenidate in Children With Attention-deficit Hyperactivity Disorder

A Phase 4 interventional study of OROS-methylphenidate in Attention Deficit Hyperactivity Disorder, sponsored by Johnson & Johnson Taiwan Ltd. Completed. Open to participants aged 6 Years to 19 Years. Per ClinicalTrials.gov, last updated 2010-04-28.

Sponsored by Johnson & Johnson Taiwan Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
520
Allocation
Non-randomized
Ages
6 Years to 19 Years
Sex
All
01

Study summary

The purpose of the study is to investigate the clinical benefit of switching children with ADHD from immediate-release methylphenidate (IR-MPH) to OROS-methylphenidate under the correct dosage conversion scheme.

Read the detailed description

This is a prospective, non-comparative study. Each patient will be treated for 10 weeks including 6-week titration phase and 4-week maintenance phase. After an initial baseline evaluation, patients currently receiving IR-Methylphenidate (IR-MPH) therapy will switch to receiving OROS-methylphenidate once daily. Patients receiving IR-MPH =15 mg per day will switch to receive 18 mg once daily OROS-methylphenidate. For patients on IR-MPH daily dosage >15 mg and =30 mg, the initial dose of OROS-methylphenidate will be 36 mg once daily. Other patients receiving IR-MPH higher than 30 mg per day, will switch to receive 54 mg once daily OROS-methylphenidate. During the 6-week titration phase, those patients who do not achieve the criteria of "Optimal Response" will be titrated by biweekly increase to next dose level (36 mg per day, and then 54 mg per day). The maximum dose of OROS-methylphenidate per day is 54 mg as package insert indicates. However, dose decreases are allowed if clinically intolerable adverse events emerge. At the end of 6-week titration phase, the final titration dose should be maintained for the last 4 weeks of the trial regardless of the optimal response. In summary, all patients will attend bi-weekly clinic visits for the first 6 weeks (visit 2 to 4) and monthly clinic visits for the subsequent 4 weeks (visit 5). Patients will receive 18 mg or 36mg or 54 mg once daily OROS-methylphenidate for 10 weeks.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • Methylphenidate
  • Attention Deficit Hyperactivity Disorder
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 520 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Johnson & Johnson Taiwan Ltd is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who used to be treated their Attention-deficit hyperactivity disorder with IR-MPH less than 70 mg/day (inclusive) for at least one month without severe adverse events or possible contraindications with MPH
  • Patients must be living with the parent/caregiver who can complete the questionnaires during the study
  • Patients or parent/caregiver without any psychotic disease or any mental situation which may cause the concern to properly complete the questionnaires

Exclusion criteria

Exclusion Criteria:

  • Known to be non-responders to methylphenidate
  • Marked anxiety, tension, aggression/agitation
  • Known or suspected mental retardation or significant learning disorder
  • Glaucoma, ongoing seizure disorder, psychotic disorder, diagnosis or family history of Tourette's disorder, bipolar disorder, eating disorder
  • Subject who require drug therapy or hospitalization for treatment of a mood or anxiety disorder
  • other psychotropic medication subject is taking at study entry could be continued during study period they were maintained at a stable dose for a minimum of 4 weeks pre-study entry
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
520 participants (actual)

Interventions

  • DrugOROS-methylphenidate
06

What researchers measure

Primary outcomes

  1. To investigate the final dosage of OROS-methylphenidate for patients achieving optimal response in 10 weeks.The optimal response is defined as a score of 0 or 1 on each of the first 18 ADHD items (referred to SNAP-IV (Swanson, Nolan and Pelham))

Secondary outcomes

  1. To describe the measurement of symptom(s)/sign(s) quality of life improvement and to describe the efficacy and the global assessment of satisfaction by parents/caregivers and patients at every visit throughout the study in 10 weeks.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00518232
Lead sponsor
Johnson & Johnson Taiwan Ltd
First posted
Aug 20, 2007
Start date
Sep 2006
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Apr 28, 2010

Study contacts

Johnson & Johnson Taiwan, Ltd. Clinical Trial
study director · Johnson & Johnson Taiwan Ltd
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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