Long-term Safety and Effectiveness of OROS Methylphenidate HCl in Children With Attention Deficit Hyperactivity Disorder

June 13, 2011 updated by: Alza Corporation, DE, USA

Long-term Safety and Effectiveness of OROS (Methylphenidate HCl) in Children With ADHD

The purpose of this study is to evaluate the long-term safety and effectiveness of OROS® Methylphenidate HCl (a central nervous system stimulant) in children with attention deficit hyperactivity disorder (ADHD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Attention Deficit Hyperactivity Disorder (ADHD) represents the most common neurobehavioral disorder in children, affecting 3% to 5% of the school-age population. Behavioral pediatricians, child psychiatrists, and child neurologists indicate that referrals for ADHD may constitute up to 50% of their practices. This is a multicenter, open-label, non-randomized, single-treatment study in children 6 to 13 years of age with ADHD who have successfully completed specific earlier ALZA studies. Part I of this study will evaluate the safety and effectiveness of OROS® (methylphenidate HCl) for a period of one year in children with ADHD. Part II of this study continues the evaluation of the safety and effectiveness of OROS® (methylphenidate HCl) in children with ADHD who have completed one year in Part I of the study. During Part I of the study, patients will be assigned to treatment with OROS® (methylphenidate HCl) 18, 36, or 54 milligrams once daily, as determined by the results from their participation in earlier ALZA studies. Patients continuing in Part II of the study continue to receive a daily dose as determined from the dosing at the end of Part I. Doses can be titrated up or down, as considered appropriate by the medical personnel at the study site, with a maximum once-daily dose of 54 milligrams. Effectiveness is determined by standardized measurements of attention, behavior, and hyperactivity including: the IOWA (Inattention Overactivity with Aggression) Conners Rating Scale, Inattention/Overactivity (I/O) and Oppositional/Defiance (O/D) subscales; Peer Interaction assessment; Global evaluation of effectiveness of therapy; and the Parent Satisfaction Questionnaire. Safety evaluations include the incidence of adverse events, physical examinations, clinical laboratory tests, vital signs, sleep quality, appetite, and the presence/severity of tics (hard-to-control, repeated twitching of any parts of the body or hard-to-control repeating of sounds or words).

Data will be summarized and no formal hypotheses will be tested. Part I: A daily morning oral dose of 18, 36, or 54 milligrams of OROS® (methylphenidate HCl) for up to 12 months. Part II: Continuation for up to 15 months of the same daily dose taken at the end of Part I. Total treatment duration to approximately 27 months.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have successfully completed one of the following earlier ALZA studies: CR005992, C-97-033 (and then successfully completed C-98-011), CR005989, or CR005995, without significant drug-related adverse events
  • whose primary care physician agrees that it is appropriate to participate in this study
  • who agree to take only the OROS® (methylphenidate HCl) supplied and no other methylphenidate dosage form or other medications for the treatment of ADHD during the study
  • who are able to comply with the study visit schedule and whose parent(s) and teachers are willing and able to complete the protocol-specified assessments
  • who have normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined not clinically significant by the investigator

Exclusion Criteria:

  • Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
  • having any coexisting medical condition or are taking any medication that is likely to interfere with safe administration of methylphenidate
  • having a known hypersensitivity to methylphenidate
  • having a history of high blood pressure or who have a blood pressure (systolic or diastolic) equal to or greater than the 95th percentile for age, gender and height
  • if female, have begun menstruation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
methylphenidate HCl
Drug: methylphenidate HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of adverse events; Changes in physical examinations, clinical laboratory tests, vital signs, sleep quality, appetite, and tics

Secondary Outcome Measures

Outcome Measure
IOWA (Inattention Overactivity with Aggression) Conners Rating Scale, Inattention/Overactivity (I/O) and Oppositional/Defiance (O/D) subscales; Peer Interaction assessment; Global evaluation of effectiveness of therapy; Parent Satisfaction Questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alza Corporation, DE, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

December 1, 1999

Study Registration Dates

First Submitted

December 22, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 26, 2005

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR006001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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