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New treatment option for Epilepsy
Official title Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
ClinicalTrials.gov ID: NCT04419272
What this study is testing
What is Methylphenidate?
Methylphenidate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for epilepsy.
Also referred to as Concerta, Ritalin, Daytrana, Aptensio XR, Metadate CD, Methylin, Quillivant XR, Jornay PM, Adhansia XR, Cotempla.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Methylphenidate (MPH) is a stimulant, FDA-approved for the treatment of attention deficit hyperactivity disorder (ADHD). It is unknown, however, if stimulants would be of benefit for memory and thinking problems due to epilepsy.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- people WITH EPILEPSY Participants will include adult people with focal-onset epilepsy, based on clinical history, imaging studies and ictal and/or...
- 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...
You likely can't join if
- people WITH EPILEPSY people 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...
- 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...
See the full eligibility criteria
- people WITH EPILEPSY Participants will include adult people with focal-onset epilepsy, based on clinical history, imaging studies and ictal and/or interictal EEG interpreted by a clinical epileptologist. Seizures may be...
- 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...
- Fluency in written and spoken English.
- 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 people and epilepsy...
- 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.
- people WITH EPILEPSY people 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 people with epilepsy will also be excluded for a diagnosis of dementia (i.e., Alzheimer's disease). people with epilepsy and cognitive complaints must have a MoCA score of...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.