ADHDPhase 3NCT00141050
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
A Phase 3 study testing Focalin XR in people with ADHD, run by Novartis at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Focalin XR
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jul 2005
- 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
- DSM-IV diagnosis of ADHD
- Males and females aged 6-12
Who cannot join
- Inability to understand or follow instructions
- Is pregnant
- Diagnosis of tic disorder
- History of seizure disorder
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
- Conditions
- ADHD
- Being tested
- Focalin XR
- Keywords
- ADHD, children
- 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.
Focalin XRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attention and deportment measured at 2 hours post-dose
Secondary outcomes (3)
Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startMay 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Matthew Brams, MD, Principal investigator, Bayou City Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141050
- Sponsor's protocol ID
- CRIT124EUS12
- Status last verified
- Dec 2007
- First submitted
- 30 Aug 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
- ClinicalTrials.gov ID
- NCT00141050
- Acronym / sponsor ID
- CRIT124EUS12
- Conditions
- ADHD
- Keywords
- ADHD, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Jul 2005 (actual)
- First posted
- 1 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.
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- DSM-IV diagnosis of ADHD
- Males and females aged 6-12
Key exclusion criteria (4 listed)
- Inability to understand or follow instructions
- Is pregnant
- Diagnosis of tic disorder
- History of seizure 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 |
|---|---|---|
| Focalin XR | Drug | – |
Primary outcome
Change in attention and deportment measured at 2 hours post-dose
3 secondary outcomes
Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
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 21 Dec 2007.
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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.
Matthew Brams, MD principal investigator
Bayou City Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Focalin XR in people with ADHD, run by Novartis 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 2 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 21 Dec 2007. 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. 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?
Change in attention and deportment measured at 2 hours post-dose. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2007.