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| ID | Type | Description | Link |
|---|---|---|---|
| shire IND#54,732 | Other Identifier | Shire Pharmaceuticals |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daytrana 9 hr wear | Experimental |
| |
| Daytrana 10 hr wear | Experimental |
| |
| Daytrana 11 hr wear | Experimental |
| |
| Daytrana 12 hr wear | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daytrana | Drug | Daytrana patch 10-30 mg administered once daily for 9hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Latency | Measure by daily subject sleep diary | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| arie ashkenasi | pediatric neurology of the ozarks | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Neurology of the Ozarks | Springfield | Missouri | 65807 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22115000 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Sequence 1 | Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun |
| FG001 | Group Sequence 2 | Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun |
| FG002 | Group Sequence 3 | Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun |
| FG003 | Group Sequence 4 | Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open Label Dose Optimization |
| |||||||||||||
| Randomized Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Sequence 1 | Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun |
| BG001 | Group Sequence 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Latency | Measure by daily subject sleep diary | 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 | Posted | Mean | 95% Confidence Interval | minutes | 9 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Sequence 1 | Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin reactions | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arie Ashkenasi, MD | CoxHealth | 011 972 50 3007477 | ashkenasi1@gmail.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Daytrana | Drug | Daytrana 10-30 mg worn once daily for 10 hr wear |
|
|
| Daytrana | Drug | Daytrana 10-30 mg worn once daily for 11 hr |
|
|
| Daytrana | Drug | Daytrana 10-30 mg worn once daily for 12 hrs |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
| BG002 | Group Sequence 3 | Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun |
| BG003 | Group Sequence 4 | Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Attention Deficit Hyperactivity Disorder (ADHD) Subtype | There are 3 subtypes of ADHD as defined by the DSM-IV-TR. Inattentive, Hyperactive/Impulsive and combined subtype (hyperactive/impulsive and inattentive). "Other subtype" refers to individuals who are not of the combined subtype but instead are either hyperactive/impulsive or inattentive type. | Number | participants |
|
| Conner's Global Impression-Parent Scale | Rating scale filled out by the parents/caregivers. Scale consists of 28 questions divided into four subscales of oppositional problems, cognitive problems, hyperactivity and an ADHD index. Questions scored on a 4 point scale (0-3; 84 points possible), where a higher score indicates more severe symptom presentation. | Mean | Standard Deviation | scores on scale |
|
| Attention Deficit Hyperactivity Disorder Rating Scale-IV Total Score | An 18-item scale corresponding to the 18 items in the DSM-IV-TR that is divided into two subsclaes: hyperactivity/impulsivity and inattentiveness. Items scored on a 4-point frequency scale ranging from 0=never/rarely to 3=very often; 54 points possible with higher score indicating more severe symptoms. Rating scale is filled out by the caregiver. | Mean | Standard Deviation | Score on scale |
|
| Sleep Latency | Sleep latency was taken by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality) | Mean | Standard Deviation | minutes |
|
| Total Sleep Time | Total sleep time was taken by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality) | Mean | Standard Deviation | hours |
|
| Sleep Quality | Sleep quality was documented by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality). Assessed on a 5 point scale (0-lowest quality; 5-highest quality) | Mean | Standard Deviation | Score |
|
Result for all patients when patch worn for 11 hrs/day
| OG003 | 12 hr Wear | Result for all patients when patch worn for 12 hrs/day |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Group Sequence 2 | Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun | 0 | 9 | 5 | 9 |
| EG002 | Group Sequence 3 | Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun | 0 | 4 | 1 | 4 |
| EG003 | Group Sequence 4 | Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun | 0 | 7 | 4 | 7 |
| Hallucinations | Nervous system disorders | Non-systematic Assessment |
|
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| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |