Attention Deficit Hyperactivity DisorderPhase 3NCT00269815
Long-term Safety and Effectiveness of OROS Methylphenidate HCl in Children With Attention Deficit Hyperactivity Disorder
A Phase 3 study testing methylphenidate HCl in people with Attention Deficit Hyperactivity Disorder, run by Alza Corporation, DE, USA.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate HCl
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, OROS®, children, methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate HClDrug
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | methylphenidate HCl Receives: Drug: methylphenidate HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events; Changes in physical examinations, clinical laboratory tests, vital signs, sleep quality, appetite, and tics
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269815
- Sponsor's protocol ID
- CR006001
- Status last verified
- Jun 2011
- First submitted
- 22 Dec 2005
- Last updated
- 14 Jun 2011
- Results posted
- No
Publications
Wilens T, McBurnett K, Stein M, Lerner M, Spencer T, Wolraich M. ADHD treatment with once-daily OROS methylphenidate: final results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2005 Oct;44(10):1015-23. doi: 10.1097/01.chi.0000173291.28688.e7.
PubMed 16175106
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety and Effectiveness of OROS (Methylphenidate HCl) in Children With ADHD
- ClinicalTrials.gov ID
- NCT00269815
- Acronym / sponsor ID
- CR006001
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, OROS®, children, methylphenidate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study completion
- Dec 1999 (actual)
- First posted
- 26 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: methylphenidate HClmethylphenidate HCl |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate HCl | Drug | 001 |
Primary outcome
Incidence of adverse events; Changes in physical examinations, clinical laboratory tests, vital signs, sleep quality, appetite, and tics
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
- Results publication: PubMed 16175106Wilens T, McBurnett K, Stein M, Lerner M, Spencer T, Wolraich M. ADHD treatment with once-daily OROS methylphenidate: final results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2005 Oct;44(10):1015-23. doi: 10.1097/01.chi.0000173291.28688.e7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alza Corporation Clinical Trial study director
ALZA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylphenidate HCl in people with Attention Deficit Hyperactivity Disorder, run by Alza Corporation, DE, USA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events; Changes in physical examinations, clinical laboratory tests, vital signs, sleep quality, appetite, and tics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00269815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.