Attention Deficit Disorder With HyperactivityPhase 3NCT00151983
Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
A Phase 3 study testing Methylphenidate Transdermal System in people with Attention Deficit Disorder With Hyperactivity, run by Noven Therapeutics at 18 sites in United States.
Trial summary
This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product. 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
- 175 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2005to Jul 2006
- Phase
- Phase 3
- 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
- Subject must have a primary diagnosis of ADHD
- Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day
- Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test
Who cannot join
- A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually
- A recent history of suspected substance abuse or dependence disorder
- Subject is taking Strattera
- Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Claghorn-Lesem Research Clinic
Bellaire, Texas
Alpine Clinical Research Center
Boulder, Colorado
North Carolina Neuropsychiatry PA
Chapel Hill, North Carolina
Ohio State University
Columbus, Ohio
NeuroScience, Inc.
Herndon, Virginia
ProMed Pediatrics
Kalamazoo, Michigan
Capstone Clinical Research
Libertyville, Illinois
Miami Research Associates, Inc.
Miami, Florida
Monarch Medical Research
Norfolk, Virginia
IPS Research Company
Oklahoma City, Oklahoma
Pedia Research, LLC
Owensboro, Kentucky
CNS Research Institute
Philadelphia, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania
Oregon Center for Clinical Investigations (OCCI, Inc.)
Portland, Oregon
ADHD Clinic of San Antonio
San Antonio, Texas
Psychiatric Centers at San Diego
San Marcos, California
Meadowbrook Research, Inc.
Scottsdale, Arizona
Children's Specialized Hospital
Toms River, New Jersey
About this study
Official title: A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.
This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
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 safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
- 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 MTS
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate Transdermal System | Active comparator | Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks Receives: Drug: Methylphenidate Transdermal System |
| Placebo patch | Placebo comparator | Placebo patch applied daily for 8 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 ADHD Rating Scale at 4 weeks
Measured: 30 days
Secondary outcomes (6)
Parent rating scale
Measured: 30 days
Parent Global Assessment
Measured: 30 days
Medication Satisfaction Survey
Measured: 30 days
ADHD Impact Module
Measured: 30 days
Clinical Global Impressions Scale
Measured: 30 days
Adverse events, lab tests, dermal evaluations, ECGs
Measured: 30 days
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 completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 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
- NCT00151983
- Sponsor's protocol ID
- SPD485-305
- Status last verified
- Jul 2015
- First submitted
- 7 Sep 2005
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bukstein OG, Arnold LE, Landgraf JM, Hodgkins P. Does switching from oral extended-release methylphenidate to the methylphenidate transdermal system affect health-related quality-of-life and medication satisfaction for children with attention-deficit/hyperactivity disorder? Child Adolesc Psychiatry Ment Health. 2009 Dec 10;3(1):39. doi: 10.1186/1753-2000-3-39.
PubMed 20003260Arnold LE, Bozzolo DR, Hodgkins P, McKay M, Beckett-Thurman L, Greenbaum M, Bukstein O, Patel A. Switching from oral extended-release methylphenidate to the methylphenidate transdermal system: continued attention-deficit/hyperactivity disorder symptom control and tolerability after abrupt conversion. Curr Med Res Opin. 2010 Jan;26(1):129-37. doi: 10.1185/03007990903437412.
PubMed 19916704
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 Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.
- ClinicalTrials.gov ID
- NCT00151983
- Acronym / sponsor ID
- SPD485-305
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Noven TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Noven Pharmaceuticals, Inc.
- Study start
- Jun 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 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 safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
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 safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate Transdermal System | Active comparator | Drug: Methylphenidate Transdermal SystemMethylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks |
| Placebo patch | Placebo comparator | Drug: Methylphenidate Transdermal SystemPlacebo patch applied daily for 8 weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject must have a primary diagnosis of ADHD
- Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day
- Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test
Key exclusion criteria (4 listed)
- A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually
- A recent history of suspected substance abuse or dependence disorder
- Subject is taking Strattera
- Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites
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: MTSTo assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo | Drug | Methylphenidate Transdermal System, Placebo patch |
Primary outcome
Score on ADHD Rating Scale at 4 weeks
Time frame: 30 days
6 secondary outcomes
Parent rating scale
Time frame: 30 days
Parent Global Assessment
Time frame: 30 days
Medication Satisfaction Survey
Time frame: 30 days
ADHD Impact Module
Time frame: 30 days
Clinical Global Impressions Scale
Time frame: 30 days
Adverse events, lab tests, dermal evaluations, ECGs
Time frame: 30 days
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.
- Derived from this study: PubMed 20003260Bukstein OG, Arnold LE, Landgraf JM, Hodgkins P. Does switching from oral extended-release methylphenidate to the methylphenidate transdermal system affect health-related quality-of-life and medication satisfaction for children with attention-deficit/hyperactivity disorder? Child Adolesc Psychiatry Ment Health. 2009 Dec 10;3(1):39. doi: 10.1186/1753-2000-3-39.
- Derived from this study: PubMed 19916704Arnold LE, Bozzolo DR, Hodgkins P, McKay M, Beckett-Thurman L, Greenbaum M, Bukstein O, Patel A. Switching from oral extended-release methylphenidate to the methylphenidate transdermal system: continued attention-deficit/hyperactivity disorder symptom control and tolerability after abrupt conversion. Curr Med Res Opin. 2010 Jan;26(1):129-37. doi: 10.1185/03007990903437412.
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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.
18 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 Attention Deficit Disorder With Hyperactivity, run by Noven Therapeutics at 18 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 3 inclusion and 4 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.
Where is the study taking place?
The record lists 18 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?
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 ADHD Rating Scale at 4 weeks (time frame: 30 days). 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 NCT00151983, 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 9 Jul 2015.