Attention Deficit Disorder With HyperactivityPhase 3NCT00151957
Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
A Phase 3 study testing Methylphenidate Transdermal System in people with Attention Deficit Disorder With Hyperactivity, run by Noven Therapeutics.
Trial summary
This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed 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?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jun 2007
- 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 participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
- Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.
Who cannot join
- Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
- Female subject is pregnant or lactating
About this study
Official title: A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
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 evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed 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 MTS
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate transdermal system | Experimental | MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks Receives: Drug: Methylphenidate Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events over 12 months.
Measured: Weekly
Secondary outcomes (4)
ADHD-RS-IV scores
Measured: Weekly
Parent Global Assessment
Measured: Weekly
Clinical Global Impressions Scale
Measured: Weekly
Child's Sleep Habits Questionnaire
Measured: Weekly
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 startOct 2004
- Primary completionJun 2007
- Study completionJun 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 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
- NCT00151957
- Sponsor's protocol ID
- SPD485-303
- Status last verified
- Mar 2017
- First submitted
- 7 Sep 2005
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Findling RL, Wigal SB, Bukstein OG, Boellner SW, Abikoff HB, Turnbow JM, Civil R. Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials. Clin Ther. 2009 Aug;31(8):1844-55. doi: 10.1016/j.clinthera.2009.08.002.
PubMed 19808143
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00151957
- Acronym / sponsor ID
- SPD485-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Noven TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Noven Pharmaceuticals, Inc.
- Study start
- Oct 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (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 evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate transdermal system | Experimental | Drug: Methylphenidate Transdermal SystemMTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
- Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.
Key exclusion criteria (2 listed)
- Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
- Female subject 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: MTSMTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks | Drug | Methylphenidate transdermal system |
Primary outcome
Treatment emergent adverse events over 12 months.
Time frame: Weekly
4 secondary outcomes
ADHD-RS-IV scores
Time frame: Weekly
Parent Global Assessment
Time frame: Weekly
Clinical Global Impressions Scale
Time frame: Weekly
Child's Sleep Habits Questionnaire
Time frame: Weekly
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 28 Mar 2017.
- Background: PubMed 19808143Findling RL, Wigal SB, Bukstein OG, Boellner SW, Abikoff HB, Turnbow JM, Civil R. Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials. Clin Ther. 2009 Aug;31(8):1844-55. doi: 10.1016/j.clinthera.2009.08.002.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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.
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 2 inclusion and 2 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Treatment emergent adverse events over 12 months. (time frame: Weekly). 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 NCT00151957, 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 28 Mar 2017.