Attention Deficit Hyperactivity DisorderPhase 3NCT00326300
A Long-Term Safety Study to Evaluate Methylphenidate HCL Tablets at Multiple Dose Levels in Adults With Attention Deficit Hyperactivity Disorder
A Phase 3 study testing methylphenidate hydrochloride extended-release tablets in people with Attention Deficit Hyperactivity Disorder, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
Trial summary
The purpose of this study is to evaluate the long-term safety of methylphenidate HCL extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity Disorder (ADHD) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate hydrochloride extended-release tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Aug 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Investigator determined diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria with symptomatology from childhood to adulthood, symptoms present before age seven years and continue to meet full DSM-IV criteria at time of assessment
- Diagnosis confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) at Baseline and Adult ADHD Investigator Symptom Rating Scale (AISRS) score of 24 or greater as determined by the Investigator at Baseline
- Global Assessment of Functioning (GAF) Scale score of 41 to 60, inclusive, at Baseline
- Minimum weight of 100 lbs (45.4 kg) at Screening
- Negative urine drug test at the Screening and Baseline Visits when tested for drugs of abuse
Who cannot join
- Known to be non-responders to methylphenidate or other stimulants for the treatment of ADHD
- History of allergy, sensitivity or contraindication to methylphenidate or components of methylphenidate HCl extended-release tablets
- Coexisting medical condition or taking concomitant medication that would interfere with safe administration of methylphenidate in the Investigator's opinion
- Known structural cardiac abnormality
- Diagnosis of or family history of Tourette's syndrome, or motor or verbal tics
- History of seizures or a seizure disorder other than febrile seizures in childhood
- Glaucoma
- Uncontrolled hyperthyroidism or hypothyroidism
About this study
Official title: An Open-Label, Dose-Titration, Long-Term Safety Study to Evaluate CONCERTA (Methylphenidate HCL) Extended-release Tablets at Doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder
The purpose of this study is to evaluate the long-term safety of methylphenidate HCL extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity Disorder (ADHD)
Read the detailed description
This is a multicenter, open-label, dose-titration, long-term study to evaluate the long-term safety of five dose levels of methylphenidate HCL extended-release tablets, 36 mg, 54 mg, 72 mg (two 36 mg tablets), 90 mg (one 36 mg tablet plus one 54 mg tablet), and 108 mg (two 54 mg tablets) per day in adults with ADHD. At the baseline visit, all patients will initiate treatment with 36 mg of methylphenidate HCL extended-release tablets. The dose will be increased in 18 mg increments every seven days (+/-2 days) until an individualized dose is achieved. An individualized dose is achieved when there is at least a 30% improvement on the ADHD Investigator Symptoms Rating Scale (AISRS) and a Clinical Global Impression - Improvement (CGI-I) score of 1 or 2, or until the maximum dose of 108 mg is achieved. If a limiting adverse event occurs, the dose will be titrated downward by 18 mg. This dose is then the individualized dose. Once an individualized dose is achieved, patients will remain on that dose for approximately six months or one year, as assigned at the time of enrollment. Patients will be given a prescription for a one-month supply of drug and a pharmacy card at each visit. Safety assessments include monitoring adverse events, blood pressure, pulse, weight, and electrocardiograms (ECG) throughout the study. The study hypothesis is that methylphenidate HCL extended-release tablets in doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg per day will have an acceptable safety profile for the management of ADHD in adults.
Patients will start treatment with 36 mg extended-release tablets of methylphenidate HCL per day. The dose will be increased in 18 mg increments every 7 days (+/-2 days) until they achieve their individualized dose or reach a maximum dose of 108 mg daily. Following the patient's titration, the patient will remain on the individualized dose for approximately 6 months or one year as determined at the time of enrollment.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate hydrochloride extended-release tablets
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Attention Deficit Disorder Adult
- 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 hydrochloride extended-release tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination
Secondary outcomes (1)
Global Assessment of Effectiveness at titration visits, Months 3, 6, 9, 12 or Early Termination; Change from Baseline in the AISRS at titration visits, Months 3, 6, 9, 12 or Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startApr 2006
- Study completionAug 2007
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)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326300
- Sponsor's protocol ID
- CR011557
- Status last verified
- Apr 2010
- First submitted
- 12 May 2006
- Last updated
- 24 May 2011
- Results posted
- No
Publications
Adler LA, Orman C, Starr HL, Silber S, Palumbo J, Cooper K, Berwaerts J, Harrison DD. Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. J Clin Psychopharmacol. 2011 Feb;31(1):108-14. doi: 10.1097/JCP.0b013e318203ea0a.
PubMed 21192153
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Titration, Long-Term Safety Study to Evaluate CONCERTA (Methylphenidate HCL) Extended-release Tablets at Doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00326300
- Acronym / sponsor ID
- CR011557
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Attention Deficit Disorder Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 16 May 2006 (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 of methylphenidate HCL extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity Disorder (ADHD)
Detailed description
This is a multicenter, open-label, dose-titration, long-term study to evaluate the long-term safety of five dose levels of methylphenidate HCL extended-release tablets, 36 mg, 54 mg, 72 mg (two 36 mg tablets), 90 mg (one 36 mg tablet plus one 54 mg tablet), and 108 mg (two 54 mg tablets) per day in adults with ADHD. At the baseline visit, all patients will initiate treatment with 36 mg of methylphenidate HCL extended-release tablets. The dose will be increased in 18 mg increments every seven days (+/-2 days) until an individualized dose is achieved. An individualized dose is achieved when there is at least a 30% improvement on the ADHD Investigator Symptoms Rating Scale (AISRS) and a Clinical Global Impression - Improvement (CGI-I) score of 1 or 2, or until the maximum dose of 108 mg is achieved. If a limiting adverse event occurs, the dose will be titrated downward by 18 mg. This dose is then the individualized dose. Once an individualized dose is achieved, patients will remain on that dose for approximately six months or one year, as assigned at the time of enrollment. Patients will be given a prescription for a one-month supply of drug and a pharmacy card at each visit. Safety assessments include monitoring adverse events, blood pressure, pulse, weight, and electrocardiograms (ECG) throughout the study. The study hypothesis is that methylphenidate HCL extended-release tablets in doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg per day will have an acceptable safety profile for the management of ADHD in adults.
Patients will start treatment with 36 mg extended-release tablets of methylphenidate HCL per day. The dose will be increased in 18 mg increments every 7 days (+/-2 days) until they achieve their individualized dose or reach a maximum dose of 108 mg daily. Following the patient's titration, the patient will remain on the individualized dose for approximately 6 months or one year as determined at the time of enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Investigator determined diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria with symptomatology from childhood to adulthood, symptoms present before age seven years and continue to meet full DSM-IV criteria at time of assessment
- Diagnosis confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) at Baseline and Adult ADHD Investigator Symptom Rating Scale (AISRS) score of 24 or greater as determined by the Investigator at Baseline
- Global Assessment of Functioning (GAF) Scale score of 41 to 60, inclusive, at Baseline
- Minimum weight of 100 lbs (45.4 kg) at Screening
- Negative urine drug test at the Screening and Baseline Visits when tested for drugs of abuse
Key exclusion criteria (8 listed)
- Known to be non-responders to methylphenidate or other stimulants for the treatment of ADHD
- History of allergy, sensitivity or contraindication to methylphenidate or components of methylphenidate HCl extended-release tablets
- Coexisting medical condition or taking concomitant medication that would interfere with safe administration of methylphenidate in the Investigator's opinion
- Known structural cardiac abnormality
- Diagnosis of or family history of Tourette's syndrome, or motor or verbal tics
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 hydrochloride extended-release tablets | Drug | – |
Primary outcome
Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination
1 secondary outcome
Global Assessment of Effectiveness at titration visits, Months 3, 6, 9, 12 or Early Termination; Change from Baseline in the AISRS at titration visits, Months 3, 6, 9, 12 or Early Termination
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 24 May 2011.
- Derived from this study: PubMed 21192153Adler LA, Orman C, Starr HL, Silber S, Palumbo J, Cooper K, Berwaerts J, Harrison DD. Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. J Clin Psychopharmacol. 2011 Feb;31(1):108-14. doi: 10.1097/JCP.0b013e318203ea0a.
- Open-Label, Dose-Titration, Long-Term Safety Study of CONCERTA (36 mg, 54 mg, 72 mg, 90 mg, 108 mg) in Adults With Attention Deficit Hyperactivity DisorderLink provided by the sponsor.
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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.
McNeil Consumer & Specialty Pharmaceuticals Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylphenidate hydrochloride extended-release tablets in people with Attention Deficit Hyperactivity Disorder, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
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 8 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 24 May 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?
Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination. 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 NCT00326300, 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 24 May 2011.