Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
NCT04419272, Phase 4, Recruiting, VA Office of Research and Development
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits | ClinicalTrials.gov |
| NCT number | NCT04419272 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 226 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Conditions | Epilepsy | ClinicalTrials.gov |
| Interventions | Methylphenidate, Placebo, Methylphenidate | ClinicalTrials.gov |
| First posted | 2020-06-05 | ClinicalTrials.gov |
| Last updated | 2026-04-20 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Conners Continuous Performance Test (CPT), Following Placebo vs. Methylphenidate | Week 8 | Conners Continuous Performance Test (CPT) d' value, a measure of attention, compared post-placebo vs. post-methylphenidate (MPH) in a double-blind, parallel group, placebo controlled, randomized design | ClinicalTrials.gov |
| Secondary | Change in Composite Measure of Cognition, Following Placebo vs. Methylphenidate | Week 8 | Scores on the MCG Paragraph (immediate and delayed recall), Symbol Digit Modality Test (SDMT), and Stroop tasks will be integrated into an omnibus outcome variable by combining performance based upon z-scores derived from normative tables. The omnibus score will be compared following placebo vs. active drug treatment. | ClinicalTrials.gov |
| Secondary | Change in Overall Quality of Life, Following Placebo vs. Methylphenidate | Week 8 | Self-reported quality of life, as assessed by the Quality of Life in Epilepsy Inventory (QOLIE-89), compared post-placebo vs. post-methylphenidate. Range of scores 0-100, with higher scores representing better quality of life. | ClinicalTrials.gov |
| Secondary | Change in Composite Measure of Cognition, Post-Open-Label | Week 16 | Scores on the MCG Paragraph (immediate and delayed recall), Symbol Digit Modality Test (SDMT), and Stroop tasks will be integrated into an omnibus outcome variable by combining performance based upon z-scores derived from normative tables. The omnibus score will be compared across baseline, Week 8, and post-open-label (Week 16) | ClinicalTrials.gov |
| Secondary | Change in Subjective Cognitive Function, Following Placebo vs. Methylphenidate | Week 8 | Self-reported cognitive function, as assessed by the attention/concentration subscale of the Quality of Life in Epilepsy Inventory (QOLIE-89), compared post-placebo vs. post-methylphenidate. | ClinicalTrials.gov |
| Secondary | Change in Subjective Cognitive Function, Post-Open-Label | Week 16 | Self-reported cognitive function, as assessed by the attention/concentration subscale of the Quality of Life in Epilepsy Inventory (QOLIE-89), compared across baseline, Week 8, and post-open-label (Week 16) | ClinicalTrials.gov |
| Secondary | Change in Overall Subjective Quality of Life, Post-Open-Label | Week 16 | Self-reported quality of life, as assessed by the Quality of Life in Epilepsy Inventory (QOLIE-89), compared across baseline, Week 8, and post-open-label. Range of scores 0-100, with higher scores representing better quality of life. | ClinicalTrials.gov |
| Secondary | Effects on Seizure Frequency | Week 8, Week 16 | Seizure occurrence will be recorded in a diary, with frequency compared across baseline, Week 8, and Week 16 | ClinicalTrials.gov |
| Secondary | Change in Conner's Continuous Performance Test (CPT), Post-Open-Label | Week 16 | Conners Continuous Performance Test (CPT) d' value, a measure of attention, with change compared across baseline, Week 8, and post-open-label (Week 16) | ClinicalTrials.gov |
| Secondary | Change in Conners Continuous Performance Test (CPT), Comparing Methylphenidate Group to Untreated Controls | Week 8, Week 16 | CPT d' will be compared over the corresponding time periods in the methylphenidate, untreated epilepsy, and healthy control groups | ClinicalTrials.gov |
| Secondary | Change in Digit Span Following Placebo vs. Methylphenidate | Week 8 | Total Digit Span score, compared post-placebo vs. post-methylphenidate. Range of scores 0-48, with higher scores indicating better performance. | ClinicalTrials.gov |
| Secondary | Change in Digit Span, Post-Open-Label | Week 16 | Total Digit Span score, with change compared across baseline, Week 8, and post-open-label (Week 16) | ClinicalTrials.gov |
| Secondary | Visual Paired Comparison Task Novelty Preference Score Following Placebo vs. Methylphenidate | Week 8 | Novelty preference score (range 0-100%), compared post-placebo vs. post-methylphenidate. Higher scores indicate better performance. (Manhattan site only) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
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 |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)