Trial Outcomes & Findings for Study of Medication Patch to Treat Children Ages 6-12 With ADHD (NCT NCT00586157)

Results Overview

Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

Baseline and 4 weeks

Results posted on

2012-11-16

Participant Flow

36 subjects signed consent, and 6 discontinued/withdrew consent prior to completing one week of treatment. The remaining 30 subjects were included in data analyses and thus reported.

Participant milestones

Participant milestones
Measure	MTS Then Placebo MTS in first intervention then Placebo in second intervention	Placebo Then MTS Placebo in first intervention then MTS in second intervention
First Intervention STARTED	15	15
First Intervention COMPLETED	14	15
First Intervention NOT COMPLETED	1	0
Second Intervention STARTED	14	15
Second Intervention COMPLETED	12	14
Second Intervention NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MTS Then Placebo MTS in first intervention then Placebo in second intervention	Placebo Then MTS Placebo in first intervention then MTS in second intervention
First Intervention Worsening behavior	1	0
Second Intervention Withdrawal by Subject	1	0
Second Intervention Worsening behavior	1	0
Second Intervention Adverse Event	0	1

Baseline Characteristics

Study of Medication Patch to Treat Children Ages 6-12 With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=30 Participants
Age, Categorical <=18 years	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	9.17 years STANDARD_DEVIATION 1.84 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Attention Deficit Hyperactivity Disorder Rating Scale	37.80 Units on a scale STANDARD_DEVIATION 9.08 • n=5 Participants
Attention Deficit Hyperactivity Disorder Rating Scale - AM	30.83 Units on a scale STANDARD_DEVIATION 11.53 • n=5 Participants
Before-School Functioning Questionnaire	40.50 Units on a Scale STANDARD_DEVIATION 11.64 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).

Outcome measures

Outcome measures
Measure	MTS (Drug A) n=30 Participants	Placebo n=29 Participants
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.	14.76 Units on a scale Standard Deviation 14.48	28.33 Units on a scale Standard Deviation 15.75

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).

Outcome measures

Outcome measures
Measure	MTS (Drug A) n=30 Participants	Placebo n=29 Participants
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.	10.03 Units on a scale Standard Deviation 13.18	23.22 Units on a scale Standard Deviation 14.91

SECONDARY outcome

Timeframe: Baseline and 4 weeks

The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian. Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88

Outcome measures

Outcome measures
Measure	MTS (Drug A) n=30 Participants	Placebo n=29 Participants
Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires	12.76 Units on a scale Standard Deviation 16.65	31.37 Units on a scale Standard Deviation 17.79

Adverse Events

MTS (Drug A)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MTS (Drug A) n=30 participants at risk	Placebo n=29 participants at risk
General disorders Loss of Appetite	43.3% 13/30 • 4 weeks	0.00% 0/29 • 4 weeks
General disorders Other	33.3% 10/30 • 4 weeks	10.3% 3/29 • 4 weeks
Gastrointestinal disorders Gastro-Intestinal	30.0% 9/30 • 4 weeks	0.00% 0/29 • 4 weeks
General disorders Insomnia	26.7% 8/30 • 4 weeks	0.00% 0/29 • 4 weeks
General disorders Headaches	16.7% 5/30 • 4 weeks	3.4% 1/29 • 4 weeks
General disorders Irritability	16.7% 5/30 • 4 weeks	3.4% 1/29 • 4 weeks
Skin and subcutaneous tissue disorders Pruritis at site	13.3% 4/30 • 4 weeks	0.00% 0/29 • 4 weeks
General disorders Rhinitis	10.0% 3/30 • 4 weeks	6.9% 2/29 • 4 weeks

Additional Information

Timothy Wilens, MD

Massachusetts General Hospital

Phone: 617-726-1731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place