Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-25 @ 12:49 PM
NCT ID:
NCT02178995
Description:
Commonly-expected side effects (anxiety, tachycardia) were routinely asked about at the end of participant visits, and responses recorded. Vital signs were checked at visits 1, 4, and 5. Fatigue was reported spontaneously by the affected participant and was not assessed routinely.
Frequency Threshold:
0
Time Frame:
During entirety of pt participation (~2 months), throughout entirety of study.
Study:
NCT02178995
Study Brief:
Methylphenidate Treatment of Attention Deficits in Epilepsy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Participants With Epilepsy (Open-label) | Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed. | None | None | 0 | 30 | 2 | 30 | View |
| Placebo, 20mg, Then 10mg (Double-blind) | Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate. Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order: Placebo, 20mg of methylphenidate, 10mg of methylphenidate. At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed. | None | None | 0 | 6 | 0 | 6 | View |
| Placebo, 10mg, Then 20mg (Double-blind) | Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate. Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order: Placebo, 10mg of methylphenidate, 20mg of methylphenidate. At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed. | None | None | 0 | 6 | 1 | 6 | View |
| 10mg, 20mg, Then Placebo (Double-blind) | Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate. Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order: 10mg of methylphenidate, 20mg of methylphenidate, Placebo. At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed. | None | None | 0 | 5 | 0 | 5 | View |
| 10mg, Placebo, Then 20mg (Double-blind) | Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate. Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order: 10mg of methylphenidate, Placebo, 20mg of methylphenidate. At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed. | None | None | 0 | 6 | 1 | 6 | View |
| 20mg, 10mg, Then Placebo (Double-blind) | Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate. Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order: 20mg of methylphenidate, 10mg of methylphenidate, Placebo. At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed. | None | None | 0 | 6 | 2 | 6 | View |
| 20mg, Placebo, Then 10mg (Double-blind) | Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate. Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order: 20mg of methylphenidate, Placebo, 10mg of methylphenidate. At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed. | None | None | 0 | 5 | 0 | 5 | View |
| 40mg, 20mg, Then Placebo (One Participant) | This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose. | None | None | 0 | 1 | 1 | 1 | View |
| Healthy Controls | Healthy controls will complete the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but will not be exposed to study medication. They are included as a control group for the open-label phase of the study (visit 1 vs visit 5) only. | None | None | 0 | 15 | 0 | 15 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anxiety/panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Increased anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |