Atorvastatin + Dietary Changes for High Cholesterol in Epilepsy

Palo Alto (17 mi)

Overseen byTanya J McDonald, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol.

Eligibility Criteria

Adults with epilepsy who have been on a Modified Atkins Diet for over a year and have high cholesterol as defined by specific guidelines. They must be at least 18 years old, have a BMI over 18.5, and their seizure medications should not have changed in the last month.

Inclusion Criteria

My seizure medication has not changed in over a month.

I am 18 years old or older.

Treatment Details

The trial is testing whether changing dietary fat composition or taking Atorvastatin (a cholesterol-lowering medication) can reduce high cholesterol levels without affecting seizure control or diet adherence in adults using ketogenic diet therapies for epilepsy.

2Treatment groups

Experimental Treatment

Active Control

Group I: Modified Atkins diet (MAD) ModificationExperimental Treatment1 Intervention

Participants will be instructed on how to change their modified Atkins diet for 12 weeks. They will replace 10% of daily dietary energy from saturated fat with poly-unsaturated fat.

Group II: StatinActive Control1 Intervention

Participants will receive 10mg of atorvastatin daily for 12 weeks

Atorvastatin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Lipitor for: