Atorvastatin + Dietary Changes for High Cholesterol in Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether atorvastatin, a cholesterol-lowering drug, combined with a special diet, can safely reduce high cholesterol in adults with epilepsy. Many with epilepsy follow a high-fat, low-carb diet to control seizures, which can sometimes increase cholesterol levels. Participants will either adjust their diet to include more healthy fats or take atorvastatin for 12 weeks. The trial seeks adults who have followed a modified Atkins diet for at least a year and have high cholesterol. As a Phase 1, Phase 2 trial, it aims to understand how the treatment works and measure its effectiveness in a smaller group, offering participants a chance to contribute to early-stage research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not be currently using statin medications to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that atorvastatin is usually well-tolerated. Some studies suggest it might help protect against seizures in those with epilepsy. While no major negative effects have been reported, participants should inform healthcare providers about any unusual symptoms during the trial.
Regarding changes to the modified Atkins diet, research indicates it is safe for adults with epilepsy. Studies have found that this high-fat diet does not harm the heart. However, some people might experience increased cholesterol levels or feel unwell when starting the diet. Participants should monitor these changes and discuss them with the trial team.
Overall, previous studies have shown both atorvastatin and the modified diet to be safe. Participants should maintain communication with their healthcare team throughout the trial to ensure their well-being.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for high cholesterol in epilepsy because they combine a medication and dietary approach that could offer new benefits. Atorvastatin, a well-known statin, is being explored alongside a modified Atkins diet to see if replacing saturated fats with poly-unsaturated fats can enhance cholesterol management. Unlike standard treatments that focus solely on medication or diet, this approach targets cholesterol from both angles, aiming for potentially better outcomes for those with epilepsy.
What evidence suggests that this trial's treatments could be effective for high cholesterol in epilepsy?
Research has shown that atorvastatin, a cholesterol-lowering medication, may help reduce seizures and inflammation, benefiting people with epilepsy. In this trial, some participants will receive atorvastatin as part of their treatment. For those considering dietary changes, the trial also includes a group following a modified Atkins diet, adjusted to include more healthy fats. This diet has been shown to reduce seizures for many people. Although cholesterol levels might initially increase with this diet, they usually return to normal within a year. Both treatments show promise for managing cholesterol and seizures in adults with epilepsy.12356
Who Is on the Research Team?
Tanya J McDonald, MD, PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either modify their Modified Atkins Diet or take atorvastatin for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atorvastatin
- Modification of dietary fat composition
Atorvastatin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
American Heart Association
Collaborator