Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

This study has been terminated.
(Study only randomized 1 subject and was determined not feasible by DSMB)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01348607
First received: May 4, 2011
Last updated: January 23, 2014
Last verified: January 2014
Results First Received: July 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Supportive Care
Conditions: Central Nervous System Tumor, Pediatric
Fatigue
Specific Disorders of Sleep
Interventions: Drug: methylphenidate hydrochloride
Drug: modafinil
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I - Methylphenidate Hydrochloride Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
Arm II -Modafinil Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
Arm III Placebo Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.

Participant Flow:   Overall Study
    Arm I - Methylphenidate Hydrochloride     Arm II -Modafinil     Arm III Placebo  
STARTED     1     0     0  
COMPLETED     1     0     0  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I - Methylphenidate Hydrochloride Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
Arm II -Modafinil Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
Arm III Placebo Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Arm I - Methylphenidate Hydrochloride     Arm II -Modafinil     Arm III Placebo     Total  
Number of Participants  
[units: participants]
  1     0     0     1  
Age  
[units: participants]
       
<=18 years     1             1  
Between 18 and 65 years     0             0  
>=65 years     0             0  
Age  
[units: years]
Mean ± Standard Deviation
  13.9             13.9  
Gender  
[units: participants]
       
Female     0             0  
Male     1             1  
Region of Enrollment  
[units: participants]
       
United States     1             1  



  Outcome Measures
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1.  Primary:   Average Daytime Napping Minutes in a Week   [ Time Frame: 29 days ]

2.  Secondary:   Adverse Events   [ Time Frame: 29 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was closed prior to completion due to a lack of feasibility and low accrual by the Data Monitoring and Safety Board (DSMB).


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cristina Burroughs, Clinical Research Administrator
Organization: SunCoast CCOP Research Base
phone: (813) 396-9237
e-mail: Cristina.Burroughs@epi.usf.edu


No publications provided


Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01348607     History of Changes
Other Study ID Numbers: SCUSF 0803, SCUSF-0803, 5U10CA081920-11
Study First Received: May 4, 2011
Results First Received: July 5, 2013
Last Updated: January 23, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board