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Trial record 50 of 439 for:    Methylphenidate

Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01100658
Recruitment Status : Terminated (Due to slow accrual)
First Posted : April 9, 2010
Results First Posted : November 22, 2011
Last Update Posted : March 27, 2015
Sponsor:
Collaborator:
Children's Cancer Research Fund United States
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions ALL, Childhood
Leukemia, Lymphoblastic
Leukemia, Lymphoblastic, Acute
Leukemia, Lymphoblastic, Acute, L1
Leukemia, Lymphoblastic, Acute, L2
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Leukemia, Lymphocytic, Acute
Leukemia, Lymphocytic, Acute, L1
Leukemia, Lymphocytic, Acute, L2
Lymphoblastic Leukemia
Lymphoblastic Leukemia, Acute
Lymphoblastic Leukemia, Acute, Childhood
Lymphoblastic Leukemia, Acute, L1
Lymphoblastic Leukemia, Acute, L2
Lymphoblastic Lymphoma
Lymphocytic Leukemia, Acute
Lymphocytic Leukemia, L1
Lymphocytic Leukemia, L2
Brain Tumors
Cancer of the Brain
Cancer of Brain
Malignant Primary Brain Tumors
Brain Neoplasms, Malignant
Interventions Drug: Methylphenidate
Drug: Placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Participant With Attention Deficit
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Participant With Attention Deficit
Hide Arm/Group Description 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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Effectiveness of Methylphenidate on Neurocognitive Components
Hide Description 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.
Time Frame Week 1 and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
No patients received treatment, therefore analysis was not done.
Arm/Group Title Participant With Attention Deficit
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior
Hide Description 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.
Time Frame Week 1 and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
No patients received treatment, therefore analysis was not done.
Arm/Group Title Participant With Attention Deficit
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description No patients received treatment, therefore no adverse events were reported.
 
Arm/Group Title Participant With Attention Deficit
Hide Arm/Group Description 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.
All-Cause Mortality
Participant With Attention Deficit
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participant With Attention Deficit
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participant With Attention Deficit
Affected / at Risk (%)
Total   0/0 
Only 1 patient was enrolled in this study, no analysis/outcome data can be reported. This patient completed baseline assessment, but withdrew from the study before beginning the medication trial. No medications/placebo were administered.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alicia Kunin-Batson
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-624-6931
EMail: kunin003@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01100658     History of Changes
Other Study ID Numbers: 2009NTLS075
0907M69644 ( Other Identifier: IRB, University of Minnesota )
First Submitted: April 7, 2010
First Posted: April 9, 2010
Results First Submitted: July 28, 2011
Results First Posted: November 22, 2011
Last Update Posted: March 27, 2015