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Could ritalin sharpen your mind if you have epilepsy?

NCT ID NCT04419272

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether methylphenidate (Ritalin), a drug used for ADHD, can improve attention and memory in adults with epilepsy. 226 participants will be randomly assigned to take either the drug or a placebo for 8 weeks, then all can take the drug for another 8 weeks. The goal is to see if it safely helps with cognitive problems common in epilepsy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methylphenidate (Ritalin, Concerta)
What this could lead to
If it works, this could offer a safe, FDA-approved medication to help with memory and attention problems in people with epilepsy.
What could go wrong
This is a phase 4 trial, but it's still uncertain if methylphenidate helps epilepsy-related cognitive issues. Stimulants can have side effects like anxiety or insomnia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 226 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. SUBJECTS WITH EPILEPSY Participants will include adult subjects with focal-onset epilepsy, based on clinical history, imaging studies and ictal and/or interictal EEG interpreted by a clinical epileptologist. Seizures may be symptomatic, idiopathic, traumatic, or non- traumatic in etiology. Subjects must have self-reported cognitive dysfunction. Subjects must also meet the following eligibility criteria: * Age 18 years of age or older; * Capacity to provide informed consent; * Ability to live independently and complete activities of daily living; * Stable seizure frequency at the time of enrollment, such that the subject's treating physician does not believe a change in ASM regimen to be warranted during the trial (ASMs should remain unchanged during the 16 weeks of participation unless absolutely required clinically due an unanticipated change in seizure frequency or severity); * Fluency in written and spoken English. 2. CONTROLS \*DO NOT UNDERGO ANY DRUG OR PLACEBO INTERVENTION Two additional subject groups will be included, to control for effects of repeated testing in the open-label extension phase: healthy subjects and epilepsy patients without cognitive complaints, who will not receive the study drug at any point during the study. Epilepsy patients without cognitive deficits must otherwise meet all of the above criteria. Healthy controls must meet the following inclusion criteria: * Age 18 years or older; * Capacity to provide informed consent; * Ability to live independently and complete activities of daily living; * Fluency in written and spoken English. Exclusion Criteria: SUBJECTS WITH EPILEPSY Subjects with epilepsy with or without cognitive complaints will be excluded from participation for: * Psychogenic, non-epileptic spells * Delirium in the past year * Other progressive neurologic illness (i.e., malignant brain tumor). A benign, stable neoplasm with no plans for resection will not be cause for exclusion. * A history of alcohol or illicit drug abuse; * Generalized tonic-clonic or other generalized motor seizure(s) within 48 hours or focal-onset seizures with impaired awareness within 24 hours of neuropsychological testing; * Status epilepticus in the past year; * Neurosurgery within the past 6 months; * Active suicidal plan/intent in the past 6 months, a history of suicide attempt in the last 2 years, more than 1 lifetime suicide attempt, and/or current high-risk suicide flag in the medical record; * Psychotic disorders * Severe anxiety (\>26 on the Beck Anxiety Inventory \[BAI\]) and impulse control disorders; * Untreated sleep disorders; * Use of narcotic or other sedating medications within 6 hours of testing (i.e., diphenhydramine); * Concurrent severe major medical illness (i.e., cancer requiring chemotherapy or resection) * Prior transient ischemic attack (TIA) or stroke Subjects with epilepsy will also be excluded for a diagnosis of dementia (i.e., Alzheimer's disease). Subjects with epilepsy and cognitive complaints must have a MoCA score of 18 or greater. Subjects with epilepsy and no cognitive complaints must have a MoCA score of 26 or greater. Subjects with epilepsy and cognitive complaints must meet additional exclusion criteria, to minimize risks of MPH: * Current pregnancy or pregnancy planned during the trial * Breastfeeding * Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or MAOI use within 14 days of beginning the trial; * Structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, or coronary artery disease (including a history of myocardial infarction, cardiac stent placement, coronary artery bypass graft surgery, or angina); * Bipolar disorders; * Concurrent use of medications for erectile dysfunction (e.g., tadalafil, sildenafil); * Use of medications that may lower seizure threshold (e.g., tramadol, bupropion) or induce psychosis (i.e., varenicline); * Known allergy or intolerance to MPH; * Uncontrolled hypertension; HEALTHY CONTROLS Healthy controls will be excluded based on the following criteria: * History of seizures, epilepsy, or psychogenic, non-epileptic spells; * Diagnosis of dementia (i.e., Alzheimer's disease), MoCA score of \<26; * Delirium in the past year; * Other progressive neurologic illness (i.e., malignant brain tumor); * Prior moderate or severe traumatic brain injury (TBI); * Mild TBI within the past 6 months; * A history of alcohol or illicit drug abuse; * Active suicidal plan/intent in the past 6 months, a history of suicide attempt in the last 2 years, more than 1 lifetime suicide attempt, and/or current high-risk suicide flag in the medical record; * Psychotic, severe anxiety (BAI \>26), or impulse control disorders; * Untreated sleep disorders; * Use of narcotic or other sedating medications within 6 hours of testing; * Ongoing major neurological or medical illness (i.e., cancer requiring chemotherapy or resection); * Prior TIA or stroke;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Miami VA Healthcare System, Miami, FL

    RECRUITING

    Miami, Florida, 33125, United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    RECRUITING

    Boston, Massachusetts, 02130-4817, United States

  • VA NY Harbor Healthcare System, New York, NY

    RECRUITING

    New York, New York, 10010-5011, United States

  • VA Portland Health Care System, Portland, OR

    RECRUITING

    Portland, Oregon, 97207-2964, United States

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