ADHDPhase 3NCT00501293

Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD

A Phase 3 study testing Methylphenidate Transdermal System in people with ADHD, run by Noven Therapeutics at 32 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD Read more about this study

Who is it for?: Ages 13 to 17 years
Conditions the study is for: ADHD
What is being tested?: Methylphenidate Transdermal System
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 32 sitesUnited States
Study dates: Aug 2007to Feb 2009
Phase: Phase 3
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 13 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

To be eligible for inclusion, each subject must fulfill each of the following criteria at the Entry visit:
The subject participated in the antecedent SPD485-409 study, and a) completed all required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose Optimization period without achieving an acceptable condition as defined by the antecedent SPD485-409 study.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Entry.
Subject's ECG results are within the normal range or not clinically significant at Entry as judged by the Investigator in conjunction with the central reader.
Females must have a negative urine pregnancy test at Entry and agree to use acceptable contraceptives throughout the study period and for 30 days the last dose of IP.
Subject and parent of legally authorized representative (LAR) are able, willing and likely to fully comply with study procedures and restrictions.
Written, signed and dated informed consent to participate in the study must be given by the subject's parent or LAR, in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
There must be documentation of the subject's assent to participate in the study indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions. Failure to object is not to be considered assent.

Who cannot join

Subjects will be excluded from the study if any of the following criteria are met at Entry:
Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance, AE, or a serious adverse event (SAE).
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
Subject is taking any medication that is excluded.
Female subject who is pregnant or lactating.

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

FutureSearch Trials
Austin, Texas
Claghorn-Lesem Research, Ltd.
Bellaire, Texas
Vermont Clinical Study Center
Burlington, Vermont
CRI Worldwide
Clementon, New Jersey
University Hospitals Case Medical Center
Cleveland, Ohio
Triangle Neuropsychiatry
Durham, North Carolina
Mountain West Clinical Trials, LLC
Eagle, Idaho
Oregon center for Clinical Investigations, Inc.
Eugene, Oregon
Dakota Clinic/Innovis Health
Fargo, North Dakota
Northwest Clinical Research Center
Friday Harbor, Washington
Sarkis Clinical Trials
Gainsville, Florida
NeuroScience, Inc.
Herndon, Virginia
Eastside Therapeutic Resource
Kirkland, Washington
Bay Area Research Institute
Lafayette, California
Shire Clinical Research Site
Lexington, Kentucky
Westex Clinical Investigations
Lubbock, Texas
Shire Clinical Research Site
Media, Pennsylvania
CNS Healthcare
Memphis, Tennessee
Adolescent Health Center
Midlothian, Virginia
Odyssey Research
Minot, North Dakota
Vince and Associates Clinical Research
Overland Park, Kansas
Four Rivers Clinical Research, Inc.
Paducah, Kentucky
CRI Worldwide
Philadelphia, Pennsylvania
OCCI, Inc
Portland, Oregon
Rhode Island Hospital
Providence, Rhode Island
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan
Northwest Behavioral Research Ctr
Roswell, Georgia
Cerebral Research, LLC
San Antonio, Texas
Melmed Center
Scottsdale, Arizona
Miami Research Associates
South Miami, Florida
Clinical Neurophysiology Services, PC
Troy, Michigan
Elite Clinical Trials Inc.
Wildomar, California

Other trials in United States

About this study

Official title: A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD

Read the detailed description

To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based on the dermal response score (DRS).

Conditions: 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 DAYTRANA
One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months

Study groups in NCT00501293
Study group	Role	What they receive
1	Experimental	Methylphenidate Transdermal System Receives: Drug: Methylphenidate Transdermal System

What is being measured

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

Systolic Blood Pressure
Measured: Baseline and 6 months
Diastolic Blood Pressure
Measured: Baseline and 6 months
Pulse Rate
Measured: Baseline and 6 months
Electrocardiogram Results (QTcF Interval)
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Measured: Baseline and 6 months
Post Sleep Questionnaire (PSQ) Quality of Sleep
Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Measured: 6 months
Weight
Measured: Baseline and 6 months
Dermal Reactions
Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Measured: 6 months

Secondary outcomes (5)

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Measured: Baseline and 6 months
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months
The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Measured: Baseline and 6 months
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: 6 months
Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.
Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: 6 months
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months
The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
Measured: Baseline and 6 months

Timeline

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

Aug 2007Feb 2009

First posted16 Jul 2007 (estimated)
Study startAug 2007
Primary completionFeb 2009
Study completionFeb 2009

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 (1)Papers the sponsor has linked to this study.
Other trials for ADHDStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00501293
Sponsor's protocol ID: SPD485-410
Status last verified: Mar 2017
First submitted: 12 Jul 2007
Last updated: 26 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Findling RL, Katic A, Rubin R, Moon E, Civil R, Li Y. A 6-month, open-label, extension study of the tolerability and effectiveness of the methylphenidate transdermal system in adolescents diagnosed with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):365-75. doi: 10.1089/cap.2009.0122.
PubMed 20973707

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

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
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

All ADHD trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT00501293
Acronym / sponsor ID: SPD485-410
Conditions: ADHD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: Noven TherapeuticsIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 16 Jul 2007 (estimated)
Results: Posted 15 Jan 2010

Clinical summary

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

To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Methylphenidate Transdermal SystemMethylphenidate Transdermal System

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

To be eligible for inclusion, each subject must fulfill each of the following criteria at the Entry visit:
The subject participated in the antecedent SPD485-409 study, and a) completed all required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose Optimization period without achieving an acceptable condition as defined by the antecedent SPD485-409 study.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Entry.
Subject's ECG results are within the normal range or not clinically significant at Entry as judged by the Investigator in conjunction with the central reader.
Females must have a negative urine pregnancy test at Entry and agree to use acceptable contraceptives throughout the study period and for 30 days the last dose of IP.

Key exclusion criteria (5 listed)

Subjects will be excluded from the study if any of the following criteria are met at Entry:
Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance, AE, or a serious adverse event (SAE).
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
Subject is taking any medication that is excluded.
Female subject who is pregnant or lactating.

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: DAYTRANAOne of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months	Drug	1

Primary outcome

Systolic Blood Pressure
Time frame: Baseline and 6 months
Diastolic Blood Pressure
Time frame: Baseline and 6 months
Pulse Rate
Time frame: Baseline and 6 months
Electrocardiogram Results (QTcF Interval)
Time frame: Baseline and 6 months
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Post Sleep Questionnaire (PSQ) Quality of Sleep
Time frame: 6 months
Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Weight
Time frame: Baseline and 6 months
Dermal Reactions
Time frame: 6 months
Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.

5 secondary outcomes

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months
Time frame: Baseline and 6 months
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months
Time frame: Baseline and 6 months
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Time frame: 6 months
Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.
Time frame: 6 months
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months
Time frame: Baseline and 6 months

Results and safety

Results posted to the registry on 15 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Antecedent Methylphenidate Transdermal System (MTS)	110	109
Antecedent Placebo	53	53

Primary outcome: Systolic Blood Pressure

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: mmHg

Measure	Antecedent Methylphenidate Transdermal System (MTS) n = 109	Antecedent Placebo n = 53
Baseline measure	113.4 (9.59)	113.0 (11.20)
6 months	115.3 (9.91)	115.9 (14.82)

Population analysed: Safety population defined as all subjects that received at least one dose of MTS.

Primary outcome: Diastolic Blood Pressure

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: mmHg

Measure	Antecedent Methylphenidate Transdermal System (MTS) n = 109	Antecedent Placebo n = 53
Baseline measure	69.4 (7.42)	67.2 (7.69)
6 months	67.9 (7.79)	68.9 (8.28)

Population analysed: Safety population

Primary outcome: Pulse Rate

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: beats per minute

Measure	Antecedent Methylphenidate Transdermal System (MTS) n = 109	Antecedent Placebo n = 53
Baseline measure	80.4 (11.34)	74.3 (9.73)
6 months	81.7 (11.60)	78.9 (12.27)

Population analysed: Safety population

Primary outcome: Electrocardiogram Results (QTcF Interval)

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: msec

Measure	Antecedent Methylphenidate Transdermal System (MTS) n = 108	Antecedent Placebo n = 52
Baseline measure	391.8 (20.76)	393.2 (17.85)
6 months	395.3 (21.22)	393.5 (21.53)

Population analysed: Safety Population

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Antecedent Methylphenidate Transdermal System (MTS)	3 of 109 (2.8%)	36 of 109 (33%)	Not reported
Antecedent Placebo	1 of 53 (1.9%)	32 of 53 (60.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20973707Findling RL, Katic A, Rubin R, Moon E, Civil R, Li Y. A 6-month, open-label, extension study of the tolerability and effectiveness of the methylphenidate transdermal system in adolescents diagnosed with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):365-75. doi: 10.1089/cap.2009.0122.
Individual participant dataSharing planned: No

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
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

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.

Robert L. Findling, M.D. principal investigator

University Hospitals Cleveland Medical Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylphenidate Transdermal System in people with ADHD, run by Noven Therapeutics at 32 sites 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 8 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites 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. 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?

Yes. Results are posted in the registry (first posted 15 Jan 2010). 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?

Systolic Blood Pressure (time frame: Baseline and 6 months). The study lists 7 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 NCT00501293, 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 26 Apr 2017.