Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning

This study has been terminated.

( Closed early due to slow accrual. )

Study NCT00418691 Information provided by M.D. Anderson Cancer Center

First Received on January 3, 2007. Last Updated on June 10, 2011 History of Changes

Results First Received: January 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Brain Tumor
Interventions:	Drug: IR Methylphenidate Drug: Modafinil Drug: SR Methylphenidate

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
Recruitment Period: March 2004 - April 2009. All recruiting done at UT MD Anderson Cancer Center, Neuro-Oncology Clinic.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 34 registered patients, one enrolled patient did not join study and therefore was never included in any group assignment.

Reporting Groups

	Description
IR Methylphenidate	Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
SR Methylphenidate	Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
Modafinil	18 mg PO once daily for 4 weeks

Participant Flow: Overall Study

	IR Methylphenidate	SR Methylphenidate	Modafinil
STARTED	11	12	10
COMPLETED	9	10	5
NOT COMPLETED	2	2	5
Lost to Follow-up	1	2	3
Started new medication voiding entry	0	0	1
Progressive Disease	1	0	1

Baseline Characteristics

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Reporting Groups

	Description
IR Methylphenidate	Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
SR Methylphenidate	Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
Modafinil	18 mg PO once daily for 4 weeks

Baseline Measures

	IR Methylphenidate	SR Methylphenidate	Modafinil	Total
Number of Participants [units: participants]	11	12	10	33
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	11	12	7	30
>=65 years	0	0	3	3
Age [units: years] Mean ± Standard Deviation	45.9 ± 10.0	41.2 ± 10.5	53.8 ± 12.9	46.6 ± 12.0
Gender [units: participants]
Female	6	6	4	16
Male	5	6	6	17
Region of Enrollment [units: participants]
United States	11	12	10	33

Outcome Measures

1. Primary:

Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score [ Time Frame: Baseline to 4-5 weeks on study medication ]

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2. Primary:

Patient Cognitive Test Scores at End of Treatment Period [ Time Frame: Baseline to end of Week 4 treatment period ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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
Early termination lead to limited analysis.

Results Point of Contact:

Name/Title: Dr. Jeffrey Wefel, Assistant Professor
Organization: UT MD Anderson Cancer Center
phone: 713-563-0514
e-mail: CR_Study_Registration@mdanderson.org

No publications provided

Responsible Party:	Jeffrey S. Wefel, PhD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00418691 History of Changes
Other Study ID Numbers:	2003-0925
Study First Received:	January 3, 2007
Results First Received:	January 10, 2011
Last Updated:	June 10, 2011
Health Authority:	United States: Institutional Review Board