Attention Deficit Hyperactivity DisorderPhase 3NCT00444574
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD
A Phase 3 study testing Methylphenidate Transdermal System and Concerta in people with Attention Deficit Hyperactivity Disorder, run by Noven Therapeutics.
Trial summary
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate Transdermal System and Concerta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Jun 2005
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male or female aged 6-12 years
- females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.
- a primary diagnosis of ADHD based on a detailed psychiatric evaluation
- a total score of =>26 on the ADHD-RS-IV at the Baseline Visit
- a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above
- no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study.
Who cannot join
- a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
- a known non-responder to psychostimulant treatment
- overweight (Body Mass Index (BMI)-for-age >90th percentile)
- a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Conduct Disorder.
- Subject has taken an investigational drug within 30 days prior to Screening.
About this study
Official title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.
Read the detailed description
This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate Transdermal System, Placebo, Concerta
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD)
- 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 Transdermal SystemDrug
Also called MTS
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
PlaceboDrug
Also called Sham treatment
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
ConcertaDrug
Also called Methylphenidate HCL
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate Transdermal System | Active comparator | Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks Receives: Drug: Methylphenidate Transdermal System |
| Placebo | Placebo comparator | Placebp matching MTS and Concerta for 7 weeks Receives: Drug: Placebo |
| Concerta | Active comparator | Methylphenidate HCL 18mg tablet 7 weeks Receives: Drug: Concerta |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit.
Measured: 7 weeks
Secondary outcomes (2)
CTRS-R, CPRS-R, CGI, PGA scores
Measured: 7 weeks
Treatment emergent AEs, dermal evaluations, PK
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startSep 2004
- Primary completionJun 2005
- Study completionJun 2005
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noven Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444574
- Sponsor's protocol ID
- SPD485-302
- Status last verified
- Jun 2015
- First submitted
- 6 Mar 2007
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Findling RL, Bukstein OG, Melmed RD, Lopez FA, Sallee FR, Arnold LE, Pratt RD. A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008 Jan;69(1):149-59. doi: 10.4088/jcp.v69n0120.
PubMed 18312050
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00444574
- Acronym / sponsor ID
- SPD485-302
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Noven TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 8 Mar 2007 (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.
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.
Detailed description
This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate Transdermal System | Active comparator | Drug: Methylphenidate Transdermal SystemMethylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebp matching MTS and Concerta for 7 weeks |
| Concerta | Active comparator | Drug: ConcertaMethylphenidate HCL 18mg tablet 7 weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- male or female aged 6-12 years
- females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.
- a primary diagnosis of ADHD based on a detailed psychiatric evaluation
- a total score of =>26 on the ADHD-RS-IV at the Baseline Visit
- a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above
Key exclusion criteria (6 listed)
- a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
- a known non-responder to psychostimulant treatment
- overweight (Body Mass Index (BMI)-for-age >90th percentile)
- a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Conduct Disorder.
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 Transdermal SystemAlso: MTSThe primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA | Drug | Methylphenidate Transdermal System |
| PlaceboAlso: Sham treatmentThe primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA | Drug | Placebo |
| ConcertaAlso: Methylphenidate HCLThe primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA | Drug | Concerta |
Primary outcome
The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit.
Time frame: 7 weeks
2 secondary outcomes
CTRS-R, CPRS-R, CGI, PGA scores
Time frame: 7 weeks
Treatment emergent AEs, dermal evaluations, PK
Time frame: 7 weeks
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 25 Jun 2015.
- Results publication: PubMed 18312050Findling RL, Bukstein OG, Melmed RD, Lopez FA, Sallee FR, Arnold LE, Pratt RD. A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008 Jan;69(1):149-59. doi: 10.4088/jcp.v69n0120.
- (FDA Recall Information)Link 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylphenidate Transdermal System and Concerta in people with Attention Deficit Hyperactivity Disorder, run by Noven Therapeutics.
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 6 inclusion and 6 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 25 Jun 2015. 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. Some participants in this study may receive a placebo. 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?
The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. (time frame: 7 weeks). 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 NCT00444574, 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 25 Jun 2015.