Attention Deficit Disorder With HyperactivityPhase 2NCT00151970
Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
A Phase 2 study testing Methylphenidate Transdermal System and Concerta in people with Attention Deficit Disorder With Hyperactivity, run by Noven Therapeutics.
Trial summary
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old 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 Disorder With Hyperactivity
- 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
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Oct 2006
- Phase
- Phase 2
- 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
- Subjects have primary diagnosis of ADHD
- Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
- Subject has an IQ score of >_ 80
- Subject is able to complete as least the Basic Test of the PERMP assessment
Who cannot join
- Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
- Subject is taking Strattera(r)
- Subject has a recent history of suspected substance abuse or dependence disorder
About this study
Official title: A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
- Being tested
- Methylphenidate Transdermal System, Placebo, Concerta
- 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
MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes
PlaceboDrug
Also called Sham Treatment
Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily
ConcertaDrug
Also called Methylphenidate HCL
CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate Transdermal System | Active comparator | The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening. Receives: Drug: Methylphenidate Transdermal System |
| Placebo | Placebo comparator | The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening. Receives: Drug: Placebo |
| Concerta | Active comparator | CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily Receives: Drug: Concerta |
What is being measured
The primary outcome is the main question the study is designed to answer.
SKAMP deportment rating scale
Measured: Week 8
Secondary outcomes (7)
PERMP age-adjusted math test
Measured: Week 8
Clinician-rated ADHD-RS-IV
Measured: Week 8
CGI-I
Measured: Week 8
Parent Global Assessment
Measured: Week 8
Connors' Parent Rating Scale
Measured: Week 8
ADHD Impact Module-Children
Measured: Week 8
SKAMP-total and inattention subscales
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noven Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Noven Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151970
- Sponsor's protocol ID
- SPD485-304
- Status last verified
- Jul 2015
- First submitted
- 7 Sep 2005
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilens TE, Boellner SW, Lopez FA, Turnbow JM, Wigal SB, Childress AC, Abikoff HB, Manos MJ. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):700-708. doi: 10.1097/CHI.0b013e31816bffdf.
PubMed 18434918Frazier TW, Weiss M, Hodgkins P, Manos MJ, Landgraf JM, Gibbins C. Time course and predictors of health-related quality of life improvement and medication satisfaction in children diagnosed with attention-deficit/hyperactivity disorder treated with the methylphenidate transdermal system. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):355-64. doi: 10.1089/cap.2009.0092.
PubMed 20973706Manos M, Frazier TW, Landgraf JM, Weiss M, Hodgkins P. HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system. Curr Med Res Opin. 2009 Dec;25(12):3001-10. doi: 10.1185/03007990903388797.
PubMed 19849639
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00151970
- Acronym / sponsor ID
- SPD485-304
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Noven TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Noven Pharmaceuticals, Inc.
- Study start
- Jun 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 9 Sep 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.
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate Transdermal System | Active comparator | Drug: Methylphenidate Transdermal SystemThe duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening. |
| Placebo | Placebo comparator | Drug: PlaceboThe duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening. |
| Concerta | Active comparator | Drug: ConcertaCONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects have primary diagnosis of ADHD
- Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
- Subject has an IQ score of >_ 80
- Subject is able to complete as least the Basic Test of the PERMP assessment
Key exclusion criteria (3 listed)
- Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
- Subject is taking Strattera(r)
- Subject has a recent history of suspected substance abuse or dependence 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: MTSMTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes | Drug | Methylphenidate Transdermal System |
| PlaceboAlso: Sham TreatmentPlacebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily | Drug | Placebo |
| ConcertaAlso: Methylphenidate HCLCONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily | Drug | Concerta |
Primary outcome
SKAMP deportment rating scale
Time frame: Week 8
7 secondary outcomes
PERMP age-adjusted math test
Time frame: Week 8
Clinician-rated ADHD-RS-IV
Time frame: Week 8
CGI-I
Time frame: Week 8
Parent Global Assessment
Time frame: Week 8
Connors' Parent Rating Scale
Time frame: Week 8
ADHD Impact Module-Children
Time frame: Week 8
SKAMP-total and inattention subscales
Time frame: Week 8
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 9 Jul 2015.
- Background: PubMed 18434918Wilens TE, Boellner SW, Lopez FA, Turnbow JM, Wigal SB, Childress AC, Abikoff HB, Manos MJ. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):700-708. doi: 10.1097/CHI.0b013e31816bffdf.
- Derived from this study: PubMed 20973706Frazier TW, Weiss M, Hodgkins P, Manos MJ, Landgraf JM, Gibbins C. Time course and predictors of health-related quality of life improvement and medication satisfaction in children diagnosed with attention-deficit/hyperactivity disorder treated with the methylphenidate transdermal system. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):355-64. doi: 10.1089/cap.2009.0092.
- Derived from this study: PubMed 19849639Manos M, Frazier TW, Landgraf JM, Weiss M, Hodgkins P. HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system. Curr Med Res Opin. 2009 Dec;25(12):3001-10. doi: 10.1185/03007990903388797.
- FDA Recall InformationLink 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 2 study testing Methylphenidate Transdermal System and Concerta in people with Attention Deficit Disorder With Hyperactivity, 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 4 inclusion and 3 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 9 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
SKAMP deportment rating scale (time frame: Week 8). 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 NCT00151970, which also lists 3 linked publications.
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 9 Jul 2015.