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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:
ClinicalTrials.gov Identifier:
NCT01348607
First Posted: May 5, 2011
Last Update Posted: February 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida
Results First Submitted: July 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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



Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01348607     History of Changes
Other Study ID Numbers: SCUSF 0803
SCUSF-0803 ( Other Identifier: SunCoast CCOP Research Base )
5U10CA081920-11 ( U.S. NIH Grant/Contract )
First Submitted: May 4, 2011
First Posted: May 5, 2011
Results First Submitted: July 5, 2013
Results First Posted: September 19, 2013
Last Update Posted: February 21, 2014