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Can a statin and diet tweak protect hearts of epilepsy patients on High-Fat diets?

NCT ID NCT06369571

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a statin drug (atorvastatin) and swapping some saturated fats for healthier ones can safely lower cholesterol in adults with epilepsy who have been on a modified Atkins diet for at least a year. The diet helps control seizures but can raise cholesterol. The trial will track diet adherence, cholesterol changes, and seizure frequency over 12 weeks in 22 participants. The goal is to find a way to manage heart risks without losing seizure control.

What this could mean

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

Active substance
Atorvastatin (Lipitor) and dietary fat modification
What this could lead to
If successful, this could offer a safe way to manage cholesterol in adults with epilepsy who need a high-fat diet for seizure control, reducing heart disease risk.
What could go wrong
This is a small, early-phase study with only 22 participants, so results may not apply widely. Statins can cause muscle pain or other side effects, and diet changes might affect seizure control.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 22 people

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

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Modified Atkins Diet use ≥ 12 months 2. Dyslipidemia based on American College of Cardiology/American Heart Association guidelines (i.e., LDL ≥190 mg/dL, 10-year ASCVD risk ≥5% with risk enhancers, etc.) 3. 18 years of age or older 4. Body mass index (BMI) \> 18.5 5. Stable anti-seizure medication regimen for \> 1 month. Exclusion Criteria: 1. \< 18 years of age 2. Body mass index (BMI) \< 18.5 3. Changes in anti-seizure medication regimen \< 1 month prior to participation 4. Known ASCVD (history of acute coronary syndrome, myocardial infarction, angina, stroke, transient ischemic attack, or peripheral artery disease) 5. Current statin medication use 6. Prior serious adverse response to atorvastatin or other statin medications 7. Uncorrected carnitine deficiency 8. Pregnancy

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Conditions

The condition(s) this trial relates to.

Dyslipidemias epilepsy inherited lipid metabolism disorder

As listed by the trial registrant

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

Dyslipidemia Epilepsy

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

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