ADHDPhase 3NCT00499863
Evaluate the Efficacy &Safety 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.
Trial summary
To assess the efficacy and safety of efficacy of MTS compared to placebo 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?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 32 sitesUnited States
- Study dates
- Jul 2007to May 2008
- 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
- Subject must meet criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2).
- Subject must have a minimum level of intellectual functioning, as determined by an IQ (based on Kaufman Brief Intelligence Test [KBIT]) score of 80 or above.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- Subject is a male or female aged 13 17 years.
- Females must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use acceptable contraceptives throughout the study period and for 30 days after the last dose of IP.
Who cannot join
- Subject has a current, controlled (requiring a restricted medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder.
- Subjects who, in the opinion of the Investigator, are acutely at risk for suicidal or violent behavior towards him/herself or others, or a history of a suicide attempt requiring medical intervention.
- Subject is overweight.
- Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Subject has Conduct Disorder.
- Subject has a positive urine drug or alcohol result at Screening (with the exception of subject's current stimulant therapy, if any).
Show all 15Show fewer
- Subject has a history of alcohol or other substance abuse or dependence.
- Subject has taken an investigational drug within 30 days prior to screening.
- Subject has any abnormal thyroid function.
- Subject has any clinically significant laboratory abnormalities.
- Subject has severe allergic rhinitis, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Mild, stable asthma is not exclusionary.
- The female subject is pregnant or lactating.
- Subject has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions which would interfere with trial assessments or compromise subject safety (e.g. dermatitis, eczema or psoriasis).
- Subject has sensitive-skin syndrome (definition: subjects who often develop nonspecific skin irritancy reactions to bland materials) or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
- Subject has clinical signs and symptoms of skin irritation (i.e., pruritus, burning, erythema) or scars or tattoos.
Trial locations and contacts
32 sites in 1 country.
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
Gainesville, 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
About this study
Official title: A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of MTS in Adolescents Aged 13-17 Years With ADHD
To assess the efficacy and safety of efficacy of MTS compared to placebo
Read the detailed description
To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.
- Conditions
- ADHD
- Being tested
- methylphenidate transdermal system, Placebo
- 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
dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
PlaceboDrug
Also called Sham treatment
Placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate Transdermal System | Experimental | dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear Receives: Drug: methylphenidate transdermal system |
| 2 | Placebo comparator | Daily application of matching MTS Placebo Patch Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint
The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (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 endpoint (up to 7 weeks)
Secondary outcomes (10)
Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint
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).
Measured: Baseline and endpoint (up to 7 weeks)
Improvement in Clinical Global Impressions-Improvement (CGI-I) Score
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: up to 7 weeks
Improvement in Parent Global Assessment (PGA) Score
Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: up to 7 weeks
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint
The Youth Quality of Life Instrument-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).
Measured: Baseline and endpoint (up to 7 weeks)
Dermal Response Scale (DRS) Scores
Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Measured: up to 7 weeks
Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint
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 endpoint (up to 7 weeks)
Change From Baseline in Pulse Rate at Endpoint
Measured: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Systolic Blood Pressure at Endpoint
Measured: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Diastolic Blood Pressure at Endpoint
Measured: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Weight at Endpoint
Measured: Baseline and endpoint (up to 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 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 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noven Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert L Finding, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499863
- Sponsor's protocol ID
- SPD485-409
- Status last verified
- Mar 2017
- First submitted
- 10 Jul 2007
- Last updated
- 26 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Findling RL, Turnbow J, Burnside J, Melmed R, Civil R, Li Y. A randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of the methylphenidate transdermal system for the treatment of ADHD in adolescents. CNS Spectr. 2010 Jul;15(7):419-30. doi: 10.1017/s1092852900000353.
PubMed 20625364
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, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of MTS in Adolescents Aged 13-17 Years With ADHD
- ClinicalTrials.gov ID
- NCT00499863
- Acronym / sponsor ID
- SPD485-409
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Noven TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Posted 11 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of efficacy of MTS compared to placebo
Detailed description
To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate Transdermal System | Experimental | Drug: methylphenidate transdermal systemdose optimization of 4 doses of the MTS transdermal patch over the same duration of wear |
| 2 | Placebo comparator | Drug: PlaceboDaily application of matching MTS Placebo Patch |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject must meet criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2).
- Subject must have a minimum level of intellectual functioning, as determined by an IQ (based on Kaufman Brief Intelligence Test [KBIT]) score of 80 or above.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- Subject is a male or female aged 13 17 years.
Key exclusion criteria (15 listed)
- Subject has a current, controlled (requiring a restricted medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder.
- Subjects who, in the opinion of the Investigator, are acutely at risk for suicidal or violent behavior towards him/herself or others, or a history of a suicide attempt requiring medical intervention.
- Subject is overweight.
- Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Subject has 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: DAYTRANAdose optimization of 4 doses of the MTS transdermal patch over the same duration of wear | Drug | Methylphenidate Transdermal System |
| PlaceboAlso: Sham treatmentPlacebo patch | Drug | 2 |
Primary outcome
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint
Time frame: baseline and endpoint (up to 7 weeks)
The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (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.
10 secondary outcomes
Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Improvement in Clinical Global Impressions-Improvement (CGI-I) Score
Time frame: up to 7 weeks
Improvement in Parent Global Assessment (PGA) Score
Time frame: up to 7 weeks
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Dermal Response Scale (DRS) Scores
Time frame: up to 7 weeks
Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Pulse Rate at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Systolic Blood Pressure at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Diastolic Blood Pressure at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Weight at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Results and safety
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 20625364Findling RL, Turnbow J, Burnside J, Melmed R, Civil R, Li Y. A randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of the methylphenidate transdermal system for the treatment of ADHD in adolescents. CNS Spectr. 2010 Jul;15(7):419-30. doi: 10.1017/s1092852900000353.
- Individual participant dataSharing planned: No
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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.
Robert L Finding, MD 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 6 inclusion and 15 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. 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?
Yes. Results are posted in the registry (first posted 11 Jun 2009). 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?
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint (time frame: baseline and endpoint (up to 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 NCT00499863, 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.