Attention Deficit Hyperactivity DisorderDaytsleepNCT00989950

Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD

A study testing Daytrana in people with Attention Deficit Hyperactivity Disorder and INSOMNIA, run by Cox Health Systems at 1 site in United States.

Completed

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

Official record

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Trial summary

Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder, INSOMNIA
What is being tested?: Daytrana
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Dec 2009to Feb 2011
Phase: Interventional
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 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

ADHD without significant comorbidity

Who cannot join

Cardiac disorder
Hypertension
Thyroid disease
Glaucoma
History of sudden death, motor tics and/or Tourette's syndrome
Hypersensitivity to methylphenidate

Trial locations and contacts

1 site in 1 country.

United States1 site

Pediatric Neurology of the Ozarks
Springfield, Missouri, 65807

Other trials in United States

About this study

Official title: Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)

Read the detailed description

Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary.

25 patients will be enrolled in order to obtain statistical significance.

Conditions: Attention Deficit Hyperactivity Disorder, INSOMNIA
Being tested: Daytrana
Keywords: daytrana, sleep latency, adhd rating scales, ADHD
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaytranaDrug
Also called methylphenidate transdermal system
Daytrana patch 10-30 mg administered once daily for 9hr
DaytranaDrug
Also called methylphenidate transdermal system
Daytrana 10-30 mg worn once daily for 10 hr wear
DaytranaDrug
Also called methylphenidate transdermal system
Daytrana 10-30 mg worn once daily for 11 hr
DaytranaDrug
Daytrana 10-30 mg worn once daily for 12 hrs

Study groups in NCT00989950
Study group	Role	What they receive
Daytrana 9 hr wear	Experimental	Not described Receives: Drug: Daytrana
Daytrana 10 hr wear	Experimental	Not described Receives: Drug: Daytrana
Daytrana 11 hr wear	Experimental	Not described Receives: Drug: Daytrana
Daytrana 12 hr wear	Experimental	Not described Receives: Drug: Daytrana

What is being measured

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

Sleep Latency
Measure by daily subject sleep diary
Measured: 9 weeks

Timeline

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

Dec 2009Feb 2011

First posted6 Oct 2009 (estimated)
Study startDec 2009
Primary completionFeb 2011
Study completionFeb 2011

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 Attention Deficit Hyperactivity DisorderStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00989950
Sponsor's protocol ID: cox002
Other IDs: shire IND#54,732
Acronym: Daytsleep
Status last verified: Jul 2012
First submitted: 30 Sep 2009
Last updated: 19 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ashkenasi A. Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder. Pediatr Neurol. 2011 Dec;45(6):381-6. doi: 10.1016/j.pediatrneurol.2011.09.003.
PubMed 22115000

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

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Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
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RecruitingObservational study
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RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
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RecruitingPhase 3
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All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT00989950
Acronym / sponsor ID: Daytsleep / cox002
Conditions: Attention Deficit Hyperactivity Disorder, INSOMNIA
Keywords: daytrana, sleep latency, adhd rating scales, ADHD
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Cox Health SystemsUniversity, hospital or other
Study start: Dec 2009
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 6 Oct 2009 (estimated)
Results: Posted 14 Jun 2012

Clinical summary

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

Detailed description

25 patients will be enrolled in order to obtain statistical significance.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Daytrana 9 hr wear	Experimental	Drug: Daytrana
Daytrana 10 hr wear	Experimental	Drug: Daytrana
Daytrana 11 hr wear	Experimental	Drug: Daytrana
Daytrana 12 hr wear	Experimental	Drug: Daytrana

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

ADHD without significant comorbidity

Key exclusion criteria (6 listed)

Cardiac disorder
Hypertension
Thyroid disease
Glaucoma
History of sudden death, motor tics and/or Tourette's syndrome

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
DaytranaAlso: methylphenidate transdermal systemDaytrana patch 10-30 mg administered once daily for 9hr	Drug	Daytrana 9 hr wear
DaytranaAlso: methylphenidate transdermal systemDaytrana 10-30 mg worn once daily for 10 hr wear	Drug	Daytrana 10 hr wear
DaytranaAlso: methylphenidate transdermal systemDaytrana 10-30 mg worn once daily for 11 hr	Drug	Daytrana 11 hr wear
DaytranaDaytrana 10-30 mg worn once daily for 12 hrs	Drug	Daytrana 12 hr wear

Primary outcome

Sleep Latency
Time frame: 9 weeks
Measure by daily subject sleep diary

Results and safety

Results posted to the registry on 14 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group Sequence 1	6	6
Group Sequence 2	9	9
Group Sequence 3	4	4
Group Sequence 4	7	7

Primary outcome: Sleep Latency

Time frame: 9 weeks. Mean (95% Confidence Interval). Unit: minutes

Measure	9 hr Wear n = 26	10 hr Wear n = 26	11 hr Wear n = 26	12 hr Wear n = 26
Value	34 (28 to 41)	34 (27 to 42)	32 (25 to 35)	34 (28 to 42)

9 hr Wear vs 10 hr Wear vs 11 hr Wear vs 12 hr Wear: Mean Difference (Final Values): 0.34 (95% CI 0 to 233), p = 0.588, ANOVA

Population analysed: All 26 subjects wore the patches for 9, 10, 11 and 12 hour wears. Results are based upon impact of patch wear time on parameter

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group Sequence 1	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Group Sequence 2	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
Group Sequence 3	0 of 4 (0%)	1 of 4 (25%)	Not reported
Group Sequence 4	0 of 7 (0%)	4 of 7 (57.1%)	Not reported

Limitations and caveats (from the sponsor): Small sample size, did not permit an examination of more specific differences among patch wear time conditions. Small sample size resulted in weaker randomization to patch wear time sequences that was not completely balanced in baseline covariates.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22115000Ashkenasi A. Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder. Pediatr Neurol. 2011 Dec;45(6):381-6. doi: 10.1016/j.pediatrneurol.2011.09.003.

Related trials for Attention Deficit Hyperactivity Disorder

RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Recruiting
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
Attention Deficit Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
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.

arie ashkenasi principal investigator

pediatric neurology of the ozarks

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

Questions about this trial

What is this clinical trial studying?

A study testing Daytrana in people with Attention Deficit Hyperactivity Disorder and INSOMNIA, run by Cox Health Systems 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 1 inclusion and 6 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 19 Jul 2012. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2012). 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?

Sleep Latency (time frame: 9 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 NCT00989950, 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 19 Jul 2012.