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Statins

Atorvastatin + Dietary Changes for High Cholesterol in Epilepsy

Phase 1 & 2

Waitlist Available

Led By Tanya J McDonald, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable anti-seizure medication regimen for > 1 month.

18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate ways to lower cholesterol levels in adults with epilepsy who are following a high-fat, low-carbohydrate ketogenic diet. The study aims to find a safe and effective way to reduce cholesterol

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Atorvastatin may cause muscle pain, fatigue, digestive problems, liver enzyme changes, and rarely memory issues or confusion. Dietary changes might lead to nutritional deficiencies or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My seizure medication has not changed in over a month.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks 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 weekly seizure frequency

Diet adherence as assessed by 3 day food records

LDL Change

+2 more

Secondary study objectives

Blood ketone change

Frequency of adverse events

Side effects data

From 2013 Phase 3 trial • 59 Patients • NCT01004406

14%

Chest pain

14%

Sinusitis

10%

Musculoskeletal pain

10%

Otitis externa

Atrial fibrillation

Catheter site haemorrhage

Ischaemic cardiomyopathy

Abdominal discomfort

Cholecystitis acute

Sinus bradycardia

Tachycardia

Medical device complication

Gallbladder disorder

Leukocytosis

Coronary artery disease

Angina unstable

Hypertensive crisis

Hypertension

Dizziness

Headache

Bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Intensive LDL-lowering Therapy (ILLT)

Standard Statin Monotherapy (SMT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 2Eligibility criteria met