ADHDPhase 4NCT00586157

Study of Medication Patch to Treat Children Ages 6-12 With ADHD

A Phase 4 study testing Methylphenidate Transdermal System in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 12 years
Conditions the study is for: ADHD, Attention Deficit Hyperactivity Disorder
What is being tested?: Methylphenidate Transdermal System
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Sep 2006to Dec 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 and female outpatients 6 to 12 years of age.
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
Participation in structured morning routine (e.g. school, camp, or other organized activities).

Who cannot join

Mental retardation (IQ <75).
Subjects with a medical condition, or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
Subjects with moderate to severe dermatological atopy.
Subjects with known structural cardiac abnormalities.
Organic brain disorders.
Seizure Disorder.

Show all 10Show fewer

Subjects with Tourette's syndrome, or a history of psychosis or bipolar disorder.
Subjects with current comorbid psychopathology that in the investigator's opinion will warrant immediate treatment or will interfere with the safe execution of the protocol (i.e. Anxiety or Major Depressive Disorder rated as moderate on CGI).
Subjects with a history of intolerable adverse effects or non-response to methylphenidate.
Pregnant or nursing females.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Cambridge, Massachusetts, 02138

Other trials in United States

About this study

Official title: Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.

Conditions: ADHD, Attention Deficit Hyperactivity Disorder
Being tested: Methylphenidate Transdermal System, Placebo
Keywords: ADHD, Attention Deficit Hyperactivity Disorder, Daytrana, MTS Patch, 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 Daytrana
Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)
PlaceboDrug
Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Study groups in NCT00586157
Study group	Role	What they receive
Methylphenidate Transdermal System (MTS)	Active comparator	Not described Receives: Drug: Methylphenidate Transdermal System
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.
Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).
Measured: Baseline and 4 weeks
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.
Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).
Measured: Baseline and 4 weeks

Secondary outcomes (1)

Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires
The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian.
Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88
Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Dec 2008

First posted4 Jan 2008 (estimated)
Study startSep 2006
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ADHDStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00586157
Sponsor's protocol ID: 2006-P-001633
Status last verified: Nov 2012
First submitted: 21 Dec 2007
Last updated: 16 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Faraone SV, Hammerness PG, Wilens TE. Reliability and Validity of the Before-School Functioning Scale in Children With ADHD. J Atten Disord. 2018 Sep;22(11):1040-1048. doi: 10.1177/1087054714564623. Epub 2015 Jan 9.
PubMed 25575616
Wilens TE, Hammerness P, Martelon M, Brodziak K, Utzinger L, Wong P. A controlled trial of the methylphenidate transdermal system on before-school functioning in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2010 May;71(5):548-56. doi: 10.4088/JCP.09m05779pur.
PubMed 20492851

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ADHD trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT00586157
Acronym / sponsor ID: 2006-P-001633
Conditions: ADHD, Attention Deficit Hyperactivity Disorder
Keywords: ADHD, Attention Deficit Hyperactivity Disorder, Daytrana, MTS Patch, Methylphenidate Transdermal System
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Sep 2006
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 4 Jan 2008 (estimated)
Results: Posted 25 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 (MTS)	Active comparator	Drug: Methylphenidate Transdermal System
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male and female outpatients 6 to 12 years of age.
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
Participation in structured morning routine (e.g. school, camp, or other organized activities).

Key exclusion criteria (10 listed)

Mental retardation (IQ <75).
Subjects with a medical condition, or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
Subjects with moderate to severe dermatological atopy.
Subjects with known structural cardiac abnormalities.
Organic brain disorders.

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: DaytranaMedication skin patch titrated to 20mg (at 10 mg and 20 mg doses)	Drug	Methylphenidate Transdermal System (MTS)
PlaceboPlacebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)	Drug	Placebo

Primary outcome

Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.
Time frame: Baseline and 4 weeks
Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.
Time frame: Baseline and 4 weeks
Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).

1 secondary outcome

Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires
Time frame: Baseline and 4 weeks

Results and safety

Results posted to the registry on 25 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MTS Then Placebo	15	14
Placebo Then MTS	15	15

Primary outcome: Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.

Time frame: Baseline and 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	MTS (Drug A) n = 30	Placebo n = 29
Value	14.76 (14.48)	28.33 (15.75)

MTS (Drug A) vs Placebo: p <.001, Z-test

Primary outcome: Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.

Time frame: Baseline and 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	MTS (Drug A) n = 30	Placebo n = 29
Value	10.03 (13.18)	23.22 (14.91)

MTS (Drug A) vs Placebo: p = .003, Z-test

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MTS (Drug A)	0 of 30 (0%)	26 of 30 (86.7%)	Not reported
Placebo	0 of 29 (0%)	7 of 29 (24.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25575616Faraone SV, Hammerness PG, Wilens TE. Reliability and Validity of the Before-School Functioning Scale in Children With ADHD. J Atten Disord. 2018 Sep;22(11):1040-1048. doi: 10.1177/1087054714564623. Epub 2015 Jan 9.
Derived from this study: PubMed 20492851Wilens TE, Hammerness P, Martelon M, Brodziak K, Utzinger L, Wong P. A controlled trial of the methylphenidate transdermal system on before-school functioning in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2010 May;71(5):548-56. doi: 10.4088/JCP.09m05779pur.

Related trials for ADHD

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
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Recruiting
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RecruitingPhase 3
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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.

Timothy Wilens, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methylphenidate Transdermal System in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital 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 3 inclusion and 10 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 16 Nov 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. (time frame: Baseline and 4 weeks). The study lists 2 primary outcomes in all. 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 NCT00586157, which also lists 2 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 16 Nov 2012.