Trial Outcomes & Findings for Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors (NCT NCT01100658)
NCT ID: NCT01100658
Last Updated: 2015-03-27
Results Overview
Child performance on neuropsychological testing (i.e., using Test of Variables of Attention \[TOVA\] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder \[ADHD\], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores \< or = 1 SD below the mean represent area of deficit.
TERMINATED
NA
1 participants
Week 1 and Week 2
2015-03-27
Participant Flow
Only 1 patient was enrolled in this study. This patient completed baseline assessment, but withdrew from the study before beginning the medication trial. No medications/placebo were administered.
Participant milestones
| Measure |
Participant With Attention Deficit
Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Participant With Attention Deficit
Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
Baseline characteristics by cohort
| Measure |
Participant With Attention Deficit
n=1 Participants
Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 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
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1 and Week 2Population: No patients received treatment, therefore analysis was not done.
Child performance on neuropsychological testing (i.e., using Test of Variables of Attention \[TOVA\] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder \[ADHD\], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores \< or = 1 SD below the mean represent area of deficit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 2Population: No patients received treatment, therefore analysis was not done.
Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function \[BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form \[CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.\] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores \> or = 60 represent areas of significant behavior concern.
Outcome measures
Outcome data not reported
Adverse Events
Participant With Attention Deficit
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alicia Kunin-Batson
Masonic Cancer Center, University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place