Trial Outcomes & Findings for Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning (NCT NCT00418691)

Results Overview

'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow "trail" made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

Baseline to 4-5 weeks on study medication

Results posted on

2020-09-23

Participant Flow

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

Of the 34 registered patients, one enrolled patient did not join study and therefore was never included in any group assignment.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	11	12	10
Overall Study COMPLETED	9	10	5
Overall Study NOT COMPLETED	2	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	1	2	3
Overall Study Started new medication voiding entry	0	0	1
Overall Study Progressive Disease	1	0	1

Baseline Characteristics

Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IR Methylphenidate n=11 Participants Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks	SR Methylphenidate n=12 Participants Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks	Modafinil n=10 Participants 18 mg PO once daily for 4 weeks	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Age, Continuous	45.9 years STANDARD_DEVIATION 10.0 • n=5 Participants	41.2 years STANDARD_DEVIATION 10.5 • n=7 Participants	53.8 years STANDARD_DEVIATION 12.9 • n=5 Participants	46.6 years STANDARD_DEVIATION 12.0 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment United States	11 participants n=5 Participants	12 participants n=7 Participants	10 participants n=5 Participants	33 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 4-5 weeks on study medication

Population: Analysis were per protocol. The z-score reflects how many standard deviations above or below the population mean a raw score is for each participant.

'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow "trail" made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean).

Outcome measures

Outcome measures
Measure	IR Methylphenidate n=11 Participants Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks	SR Methylphenidate n=12 Participants Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks	Modafinil n=10 Participants 18 mg PO once daily for 4 weeks
Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score	-4.7 z-scores Standard Deviation 9.2	0.24 z-scores Standard Deviation 1.0	-3.7 z-scores Standard Deviation 4.1

PRIMARY outcome

Timeframe: Baseline to end of Week 4 treatment period

For cognitive assessment, set of widely used standardized psychometric instruments shown to be sensitive to neurotoxic effects of cancer treatment. Measures assess attention span (Digit Span), graphomotor speed (Digit Symbol), memory (Hopkins Verbal Memory Test-Revised), verbal fluency (Controlled Oral Words Association), visual motor scanning speed (Trail Making Test Part A), executive function (Trail Making Test Part B); motor speed and dexterity (Grooved Pegboard).

Outcome measures

Outcome data not reported

Adverse Events

IR Methylphenidate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SR Methylphenidate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modafinil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Wefel, PHD/ Associate Professor, Neuropsychology

UT MD Anderson Cancer Center

Phone: 713-563-0514

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place