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Stimulant
Methylphenidate for Epilepsy-Related Cognitive Deficits
Phase 4
Recruiting
Led By Beth Leeman-Markowski, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Capacity to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8, week 16
Awards & highlights
Study Summary
This trial is testing whether the stimulant methylphenidate can help improve memory and thinking in adults with epilepsy.
Who is the study for?
Adults over 18 with focal-onset epilepsy and self-reported cognitive issues can join this trial. They must be able to consent, live independently, speak English fluently, and have a stable seizure frequency without expected medication changes. Excluded are those with severe anxiety or impulse control disorders, untreated sleep disorders, major illnesses like cancer requiring active treatment, history of stroke or TIA (transient ischemic attack), psychotic disorders, recent neurosurgery or seizures close to testing times.Check my eligibility
What is being tested?
The study is testing if Methylphenidate (MPH), known for treating ADHD, can also help adults with epilepsy improve memory and thinking problems. Participants will either receive MPH or a placebo without knowing which one they're taking. Their attention and memory will be tested before starting the pills at Week 8 and again at Week 16 after everyone has had the chance to take MPH.See study design
What are the potential side effects?
Potential side effects of Methylphenidate include nervousness, trouble sleeping, loss of appetite, weight loss, dizziness; more serious ones could involve heart palpitations or increased blood pressure. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I understand the study and can agree to participate.
Select...
I have epilepsy that starts in one area of my brain, confirmed by tests and a specialist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8, week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8, week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Conners Continuous Performance Test (CPT), Following Placebo vs. Methylphenidate
Secondary outcome measures
Methylphenidate
Change in Composite Measure of Cognition, Post-Open-Label
Change in Conner's Continuous Performance Test (CPT), Post-Open-Label
+9 moreOther outcome measures
Change in Adverse Events Post-Open-Label
Change in Adverse Events, Post-Placebo vs. Post-Methylphenidate
Change in Mood Post-Open-Label
+1 moreSide effects data
From 2020 Phase 4 trial • 267 Patients • NCT0203990851%
Appetite Loss
40%
Insomnia
33%
Irritability
29%
Picking at skin, nailbiting
21%
Worried/Anxious
21%
Dull, tired, listless
19%
Tearful, depressed
18%
Stomachache
13%
Headache
13%
Motor Tics
12%
Buccal-lingual movements
10%
Social Withdrawal
1%
Hospitalized
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 - Placebo First
Phase 1-Medication First
Phase 2 - 7-Day Dosing
Phase 2 - 5-Day Dosing
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label MethylphenidateExperimental Treatment1 Intervention
All subjects will be offered open-label methylphenidate during Weeks 9-16. the dosage of MPH will begin at 10mg twice per day, at 8am and 12pm, for one week. The dosage will then increase to 20mg twice daily, at 8am and 12pm, for the next 7 weeks.
Group II: MethylphenidateExperimental Treatment1 Intervention
Subjects who will receive methylphenidate in the double-blinded period; when assigned to the active drug, the dosage of MPH will begin at 10mg twice per day, at 8am and 12pm, for one week. The dosage will then increase to 20mg twice daily, at 8am and 12pm, for the next 7 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Subjects who will receive placebo in the double-blinded period; when assigned to receive the placebo during the double-blinded period, subjects will be given a sugar pill for 8 weeks. The sugar pill will be taken twice per day, at 8am and 12pm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
FDA approved
Find a Location
Who is running the clinical trial?
Portland VA Medical CenterFED
41 Previous Clinical Trials
7,116 Total Patients Enrolled
Miami VA Healthcare SystemFED
17 Previous Clinical Trials
2,175 Total Patients Enrolled
1 Trials studying Epilepsy
VA Boston Healthcare SystemFED
68 Previous Clinical Trials
970,226 Total Patients Enrolled
1 Trials studying Epilepsy
80 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am healthy, live independently, and can manage my daily activities.I am 18 years old or older.I have epilepsy.I can take care of myself and do my daily activities on my own.I am 18 years old or older.I have epilepsy that starts in one area of my brain, confirmed by tests.I have epilepsy and have never had a stroke or a transient ischemic attack.I have epilepsy and haven't recently used sedating medications.I do not have epilepsy or non-epileptic seizures.I have epilepsy and do not have untreated sleep disorders.My seizures have been happening at a consistent rate recently.I do not have severe anxiety, psychosis, or impulse control disorders along with my epilepsy.I have not had delirium in the past year.I have epilepsy and do not abuse alcohol or drugs.My seizures are stable, and my doctor doesn't see a need to change my seizure medication during the trial.I do not have epilepsy or recent seizures.I have not had a severe seizure episode in the last year.I am 18 years old or older and healthy.I understand the study and can agree to participate.I do not have epilepsy or any worsening neurological condition.I do not have epilepsy.I am 18 years or older and in good health.I do not have epilepsy with severe major medical illness.I have epilepsy that starts in one area of my brain, confirmed by tests and a specialist.I do not have epilepsy or recent neurosurgery.I have never had seizures, epilepsy, or similar conditions.I do not have epilepsy, am not pregnant, breastfeeding, or taking certain medications that could affect the study.I am healthy and can understand and agree to the study's requirements.I can live on my own and manage my daily activities.I can live on my own and manage my daily activities.I understand and can agree to the study's procedures and risks.I feel like my thinking or memory has gotten worse.Your IQ is equal to or greater than 85, as measured by the Wonderlic test.
Research Study Groups:
This trial has the following groups:- Group 1: Methylphenidate
- Group 2: Placebo
- Group 3: Open-Label Methylphenidate
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ambition of this research?
"The prime purpose of this study, to be assessed over Week 8, is to measure the alteration in Conner's Continuous Performance Test (CPT) between pre- and post-placebo/methylphenidate. Besides that, there will also be investigations into changes in CPT d' value after open label administration at week 16; seizures frequency comparison against baseline and week 8; as well as contrasting CPT metrics across the methylphenidate group versus untreated epilepsy patients or healthy controls respectively."
Answered by AI
Is the enrollment process currently open for this research trial?
"According to clinicaltrials.gov, this study that was initially posted on January 1st 2023 is not currently enrolling patients. However, there are over 800 other medical studies recruiting individuals around the world at present time."
Answered by AI
To what extent is this experiment being conducted in medical centers?
"Currently, the trial is enrolling participants at Manhattan Campus of the VA NY Harbor Healthcare System in New york City, VA Portland Health Care System in Oregon, and Miami VA Healthcare System in Florida. Moreover, there are 7 additional sites offering this study."
Answered by AI
To what extent has recruitment to this trial been successful?
"At this moment, enrollment for the given trial has been put on pause. It was previously posted on January 1st 2023 and last updated October 18th 2022. If you are exploring other clinical trials, 819 studies related to aura have openings while 29 Methylphenidate research projects need more participants."
Answered by AI
Has Methylphenidate earned the approval of the Food and Drug Administration?
"Clinical data and the Phase 4 status of Methylphenidate lead to an assessment of 3 for this drug's safety."
Answered by AI
Could you provide a summary of prior research related to Methylphenidate?
"Methylphenidate was initially trialed in 2002 by PRODAH at the Hospital de Clínicas de Porto Alegre. This drug has been subject to 18,469 completed studies and presently there are 29 active experiments occuring across New york City."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Miami VA Healthcare System, Miami, FL
Why did patients apply to this trial?
Improve my chronic health condition of seizures.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long does the clinical trial last?
PatientReceived no prior treatments
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