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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

Must not have

Subjects with epilepsy will be excluded for prior transient ischemic attack or stroke

Subjects with epilepsy will be excluded for recent use of sedating medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8, week 16

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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 below

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I am 18 years old or older.

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I understand the study and can agree to participate.

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I have epilepsy that starts in one area of my brain, confirmed by tests and a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have epilepsy and have never had a stroke or a transient ischemic attack.

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I have epilepsy and haven't recently used sedating medications.

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I do not have epilepsy or non-epileptic seizures.

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I have epilepsy and do not have untreated sleep disorders.

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I have epilepsy and do not abuse alcohol or drugs.

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I do not have epilepsy or recent seizures.

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I have not had a severe seizure episode in the last year.

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I do not have epilepsy or any worsening neurological condition.

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I do not have epilepsy.

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I do not have epilepsy or recent neurosurgery.

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I have never had seizures, epilepsy, or similar conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8, week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8, week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Conners Continuous Performance Test (CPT), Following Placebo vs. Methylphenidate

Secondary study objectives

Methylphenidate

Change in Composite Measure of Cognition, Post-Open-Label

Change in Conner's Continuous Performance Test (CPT), Post-Open-Label

+9 more

Other study objectives

Change in Adverse Events Post-Open-Label

Change in Adverse Events, Post-Placebo vs. Post-Methylphenidate

Change in Mood Post-Open-Label

+1 more

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908

51%

Appetite Loss

40%

Insomnia

33%

Irritability

29%

Picking at skin, nailbiting

21%

Dull, tired, listless

21%

Worried/Anxious

19%

Tearful, depressed

18%

Stomachache

13%

Headache

13%

Motor Tics

12%

Buccal-lingual movements

10%

Social Withdrawal

Hospitalized

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1-Medication First

Phase 1 - Placebo First

Phase 2 - 7-Day Dosing

Phase 2 - 5-Day Dosing

Awards & Highlights

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.

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

0 / 14Eligibility criteria met