Attention Deficit Disorder With HyperactivityPhase 2NCT00466791
Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
A Phase 2 study testing Methylphenidate Transdermal System in people with Attention Deficit Disorder With Hyperactivity, run by Noven Therapeutics at 1 site in United States.
Trial summary
Evaluate the behavioral effects of MTS in children aged 6-12 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to May 2005
- 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
- Primary diagnosis ADHD
- Total score of greater than or equal to 26 on ADHD-RS-IV
- IQ of greater than or equal to 80
- Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline
Who cannot join
- Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
- Known nonresponder to psychostimulant treatment
- BMI for age greater than 90th percentile
- History of seizures during last 2 years
- Conduct Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI Child Development Center
Irvine, California, 92612
About this study
Official title: A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
Read the detailed description
Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD
- Being tested
- Methylphenidate Transdermal System
- 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 ADHD Patch
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate Transdermal System | Active comparator | Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks Receives: Drug: Methylphenidate Transdermal System |
| Placebo | Placebo comparator | Transdermal patch, 0mg, daily for 11 weeks Receives: Drug: Methylphenidate Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
Measured: 2,3,4.5,6,7.5,9,10.5 and 12 hours
Secondary outcomes (5)
PERMP scores
Measured: pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application
Clinician-rated ADHD-RS-IV score
Measured: 2,3,4.5,6,7.5,9,10.5 and 12 hours
CGI-I score
Measured: Weeks 1-9
PGA
Measured: Weeks 1-9
CPRS-R score
Measured: Weeks 1-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startAug 2004
- Primary completionMay 2005
- Study completionMay 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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 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
- NCT00466791
- Sponsor's protocol ID
- SPD485-201
- Status last verified
- Jun 2015
- First submitted
- 25 Apr 2007
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006 Feb;9(3):476-85. doi: 10.1177/1087054705284089.
PubMed 16481664
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 II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00466791
- Acronym / sponsor ID
- SPD485-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Noven TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 27 Apr 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.
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
Detailed description
Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate Transdermal System | Active comparator | Drug: Methylphenidate Transdermal SystemTransdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks |
| Placebo | Placebo comparator | Drug: Methylphenidate Transdermal SystemTransdermal patch, 0mg, daily for 11 weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primary diagnosis ADHD
- Total score of greater than or equal to 26 on ADHD-RS-IV
- IQ of greater than or equal to 80
- Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline
Key exclusion criteria (5 listed)
- Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
- Known nonresponder to psychostimulant treatment
- BMI for age greater than 90th percentile
- History of seizures during last 2 years
- 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: ADHD PatchPlacebo | Drug | Methylphenidate Transdermal System, Placebo |
Primary outcome
Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
Time frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours
5 secondary outcomes
PERMP scores
Time frame: pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application
Clinician-rated ADHD-RS-IV score
Time frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours
CGI-I score
Time frame: Weeks 1-9
PGA
Time frame: Weeks 1-9
CPRS-R score
Time frame: Weeks 1-9
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 16481664McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006 Feb;9(3):476-85. doi: 10.1177/1087054705284089.
- FDA-approved labelling information, US onlyLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate Transdermal System in people with Attention Deficit Disorder With Hyperactivity, run by Noven Therapeutics at 1 site in United States.
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 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 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS (time frame: 2,3,4.5,6,7.5,9,10.5 and 12 hours). 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 NCT00466791, 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.