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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 belowSelect...
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
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 moreSecondary study objectives
Blood ketone change
Frequency of adverse events
Side effects data
From 2013 Phase 3 trial • 59 Patients • NCT0100440614%
Chest pain
14%
Sinusitis
10%
Musculoskeletal pain
10%
Otitis externa
5%
Catheter site haemorrhage
5%
Abdominal discomfort
5%
Atrial fibrillation
5%
Ischaemic cardiomyopathy
5%
Cholecystitis acute
5%
Sinus bradycardia
5%
Tachycardia
5%
Gallbladder disorder
5%
Medical device complication
5%
Leukocytosis
5%
Coronary artery disease
5%
Angina unstable
5%
Hypertensive crisis
5%
Hypertension
5%
Dizziness
5%
Headache
5%
Bradycardia
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,332 Previous Clinical Trials
14,874,878 Total Patients Enrolled
19 Trials studying Epilepsy
1,467 Patients Enrolled for Epilepsy
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,155 Total Patients Enrolled
2 Trials studying Epilepsy
639 Patients Enrolled for Epilepsy
Tanya J McDonald, MD, PhDPrincipal InvestigatorJohns Hopkins University