Trial Outcomes & Findings for A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms (NCT NCT00541346)
NCT ID: NCT00541346
Last Updated: 2014-02-06
Results Overview
This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
COMPLETED
PHASE3
16 participants
Baseline, 8 weeks
2014-02-06
Participant Flow
16 enrolled Study Start Date: September, 2007 Study Completion Date:May, 2009 Seen at OU Physician's Child Study Center.
Participant milestones
| Measure |
Methylphenidate Transdermal System
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Baseline
STARTED
|
16
|
|
Baseline
COMPLETED
|
16
|
|
Baseline
NOT COMPLETED
|
0
|
|
Follow-up
STARTED
|
16
|
|
Follow-up
COMPLETED
|
15
|
|
Follow-up
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Methylphenidate Transdermal System
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Follow-up
Adverse Event
|
1
|
Baseline Characteristics
A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
Baseline characteristics by cohort
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Age, Categorical
<=18 years
|
16 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
|
7.83 years
STANDARD_DEVIATION 1.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
Baseline: ADHD-RS-IV Total Score
|
39.9 units on a scale
Standard Deviation 7.7
|
|
Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
Follow-Up: ADHD-RS-IV Total Score
|
13.8 units on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
Baseline: ABC HYPERACTIVITY
|
34.1 units on a scale
Standard Deviation 8.3
|
|
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
Follow-up: ABC HYPERACTIVITY
|
11.3 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems).
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
Baseline: ABC Irritability
|
19.8 units on a scale
Standard Deviation 9.6
|
|
Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
Follow-up: ABC Irritability
|
9.1 units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
Baseline: ABC Lethargy
|
11.3 units on a scale
Standard Deviation 4.9
|
|
Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
Follow-up: ABC Lethargy
|
4.5 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems).
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
Baseline: ABC Stereotypy
|
5.6 units on a scale
Standard Deviation 5.4
|
|
Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
Follow-up: ABC Stereotypy
|
1.3 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems).
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
Baseline: ABC Inappropriate Speech
|
5.5 units on a scale
Standard Deviation 2.9
|
|
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
Follow-up: ABC Inappropriate Speech
|
2.1 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning.
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit
Baseline: LPS Total
|
26.6 units on a scale
Standard Deviation 9.0
|
|
Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit
Follow-up: LPS Total
|
39.9 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported.
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit
Baseline: FAM-III Overall
|
55.7 units on a scale
Standard Deviation 4.1
|
|
Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit
Follow-up: FAM-III Overall
|
53.5 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area.
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit
Baseline: PEDI Self-Care
|
28.8 units on a scale
Standard Deviation 7.0
|
|
Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit
Follow-up: PEDI Self-Care
|
32.5 units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area.
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=16 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit
Baseline: PEDI Social Function
|
9.3 units on a scale
Standard Deviation 5.0
|
|
Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit
Follow-up: PEDI Social Function
|
14.9 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
Outcome measures
| Measure |
Methylphenidate Transdermal System
n=12 Participants
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit
Baseline: ADHDRS Teacher Total
|
32.6 units on a scale
Standard Deviation 8.9
|
|
Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit
Follow-up: ADHDRS Teacher Total
|
28.0 units on a scale
Standard Deviation 14.4
|
Adverse Events
Methylphenidate Transdermal System
Serious adverse events
| Measure |
Methylphenidate Transdermal System
n=16 participants at risk
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Nervous system disorders
tic
|
6.2%
1/16 • 8 weeks
|
Other adverse events
| Measure |
Methylphenidate Transdermal System
n=16 participants at risk
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
|
|---|---|
|
Nervous system disorders
Headache
|
18.8%
3/16 • 8 weeks
|
|
Infections and infestations
fever
|
43.8%
7/16 • 8 weeks
|
|
Psychiatric disorders
irritability
|
25.0%
4/16 • 8 weeks
|
|
Metabolism and nutrition disorders
appetite, loss of
|
18.8%
3/16 • 8 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • 8 weeks
|
|
General disorders
nose, inflammation of
|
6.2%
1/16 • 8 weeks
|
|
Psychiatric disorders
sleeping, difficulty
|
6.2%
1/16 • 8 weeks
|
|
Gastrointestinal disorders
vomiting
|
12.5%
2/16 • 8 weeks
|
|
Gastrointestinal disorders
diarrhea
|
12.5%
2/16 • 8 weeks
|
|
Gastrointestinal disorders
increased salivation
|
6.2%
1/16 • 8 weeks
|
|
Gastrointestinal disorders
blood in stool
|
6.2%
1/16 • 8 weeks
|
|
Gastrointestinal disorders
constipation
|
6.2%
1/16 • 8 weeks
|
|
Eye disorders
eyes bloodshot
|
6.2%
1/16 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
6.2%
1/16 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
6.2%
1/16 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
6.2%
1/16 • 8 weeks
|
|
Ear and labyrinth disorders
earache
|
6.2%
1/16 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
25.0%
4/16 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
6.2%
1/16 • 8 weeks
|
|
Psychiatric disorders
enuresis
|
6.2%
1/16 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
skin, dry
|
6.2%
1/16 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
sores under nose
|
6.2%
1/16 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
irritation 'burning' application site, patch
|
6.2%
1/16 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
hives
|
6.2%
1/16 • 8 weeks
|
|
Psychiatric disorders
less social
|
6.2%
1/16 • 8 weeks
|
|
Immune system disorders
allergies
|
6.2%
1/16 • 8 weeks
|
|
Eye disorders
itchy eyes
|
6.2%
1/16 • 8 weeks
|
Additional Information
Thomas M. Lock, M.D.
University of Oklahoma Health Sciences Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60