Trial · NCT00418691
Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning
NCT00418691, Phase 3, Terminated, M.D. Anderson Cancer Center; results first posted 2011-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning. Trials, record NCT00418691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00418691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning
- NCT number
- NCT00418691
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Brain Tumor
- Interventions
- IR Methylphenidate, Modafinil, SR Methylphenidate
- First posted
- 2007-01-05
- Last updated
- 2020-09-23
- Results first posted
- 2011-05-06
- Limitations and caveats
- Early termination lead to limited analysis.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score | Baseline to 4-5 weeks on study medication | '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). |
| Primary | Patient Cognitive Test Scores at End of Treatment Period | 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). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score | Baseline to 4-5 weeks on study medication | 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. | z-scores | MEAN |
| PRIMARY | Patient Cognitive Test Scores at End of Treatment Period | Baseline to end of Week 4 treatment period |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score | IR Methylphenidate | -4.7 | Standard Deviation 9.2 | z-scores | |
| Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score | SR Methylphenidate | 0.24 | Standard Deviation 1.0 | z-scores | |
| Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score | Modafinil | -3.7 | Standard Deviation 4.1 | z-scores |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IR Methylphenidate | 11 | |
| Overall Study | STARTED | SR Methylphenidate | 12 | |
| Overall Study | STARTED | Modafinil | 10 | |
| Overall Study | COMPLETED | IR Methylphenidate | 9 | |
| Overall Study | COMPLETED | SR Methylphenidate | 10 | |
| Overall Study | COMPLETED | Modafinil | 5 | |
| Overall Study | NOT COMPLETED | IR Methylphenidate | 2 | |
| Overall Study | NOT COMPLETED | SR Methylphenidate | 2 | |
| Overall Study | NOT COMPLETED | Modafinil | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IR Methylphenidate | ||
| Total, all-cause mortality | SR Methylphenidate | ||
| Total, all-cause mortality | Modafinil | ||
| Total, other adverse events | IR Methylphenidate | 0 | 11 |
| Total, other adverse events | SR Methylphenidate | 0 | 12 |
| Total, other adverse events | Modafinil | 0 | 10 |
| Total, serious adverse events | IR Methylphenidate | 0 | 11 |
| Total, serious adverse events | SR Methylphenidate | 0 | 12 |
| Total, serious adverse events | Modafinil | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00418691
GET https://conductscience.org/api/trials/v1/NCT00418691/registered