Trial Outcomes & Findings for Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD (NCT NCT00989950)
NCT ID: NCT00989950
Last Updated: 2012-07-19
Results Overview
Measure by daily subject sleep diary
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
9 weeks
Results posted on
2012-07-19
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Open Label Dose Optimization
STARTED
|
6
|
9
|
4
|
7
|
|
Open Label Dose Optimization
COMPLETED
|
6
|
9
|
4
|
7
|
|
Open Label Dose Optimization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomized Phase
STARTED
|
6
|
9
|
4
|
7
|
|
Randomized Phase
COMPLETED
|
5
|
8
|
4
|
7
|
|
Randomized Phase
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Randomized Phase
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Randomized Phase
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Baseline characteristics by cohort
| Measure |
Group Sequence 1
n=6 Participants
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
|
Group Sequence 2
n=9 Participants
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
|
Group Sequence 3
n=4 Participants
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
|
Group Sequence 4
n=7 Participants
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
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Attention Deficit Hyperactivity Disorder (ADHD) Subtype
Combined Subtype
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Attention Deficit Hyperactivity Disorder (ADHD) Subtype
Other Subtype
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Conner's Global Impression-Parent Scale
|
13.7 scores on scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
20.1 scores on scale
STANDARD_DEVIATION 6.8 • n=7 Participants
|
25 scores on scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
20.3 scores on scale
STANDARD_DEVIATION 6.7 • n=4 Participants
|
19.78 scores on scale
STANDARD_DEVIATION 6.8 • n=21 Participants
|
|
Attention Deficit Hyperactivity Disorder Rating Scale-IV Total Score
|
27 Score on scale
STANDARD_DEVIATION 11 • n=5 Participants
|
37 Score on scale
STANDARD_DEVIATION 9.2 • n=7 Participants
|
41 Score on scale
STANDARD_DEVIATION 10.2 • n=5 Participants
|
33.7 Score on scale
STANDARD_DEVIATION 10.6 • n=4 Participants
|
34.7 Score on scale
STANDARD_DEVIATION 11 • n=21 Participants
|
|
Sleep Latency
|
22.5 minutes
STANDARD_DEVIATION 12.6 • n=5 Participants
|
23.3 minutes
STANDARD_DEVIATION 21.8 • n=7 Participants
|
54.5 minutes
STANDARD_DEVIATION 64.8 • n=5 Participants
|
50.7 minutes
STANDARD_DEVIATION 12.4 • n=4 Participants
|
37.8 minutes
STANDARD_DEVIATION 27.9 • n=21 Participants
|
|
Total Sleep Time
|
9.9 hours
STANDARD_DEVIATION .9 • n=5 Participants
|
9.5 hours
STANDARD_DEVIATION .9 • n=7 Participants
|
10.6 hours
STANDARD_DEVIATION 1.2 • n=5 Participants
|
9.6 hours
STANDARD_DEVIATION 1.8 • n=4 Participants
|
9.9 hours
STANDARD_DEVIATION 1.8 • n=21 Participants
|
|
Sleep Quality
|
4.3 Score
STANDARD_DEVIATION .8 • n=5 Participants
|
4 Score
STANDARD_DEVIATION 1 • n=7 Participants
|
4 Score
STANDARD_DEVIATION .8 • n=5 Participants
|
3.1 Score
STANDARD_DEVIATION .7 • n=4 Participants
|
3.9 Score
STANDARD_DEVIATION .8 • n=21 Participants
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: 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
Measure by daily subject sleep diary
Outcome measures
| Measure |
9 hr Wear
n=26 Participants
Result for all patients when patch worn for 9 hrs/day
|
10 hr Wear
n=26 Participants
Result for all patients when patch worn for 10 hrs/day
|
11 hr Wear
n=26 Participants
Result for all patients when patch worn for 11 hrs/day
|
12 hr Wear
n=26 Participants
Result for all patients when patch worn for 12 hrs/day
|
|---|---|---|---|---|
|
Sleep Latency
|
34 minutes
Interval 28.0 to 41.0
|
34 minutes
Interval 27.0 to 42.0
|
32 minutes
Interval 25.0 to 35.0
|
34 minutes
Interval 28.0 to 42.0
|
Adverse Events
Group Sequence 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group Sequence 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group Sequence 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group Sequence 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group Sequence 1
n=6 participants at risk
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
|
Group Sequence 2
n=9 participants at risk
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
|
Group Sequence 3
n=4 participants at risk
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
|
Group Sequence 4
n=7 participants at risk
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
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
skin reactions
|
33.3%
2/6 • Number of events 4
|
55.6%
5/9 • Number of events 7
|
25.0%
1/4 • Number of events 2
|
57.1%
4/7 • Number of events 6
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place