A Phase 3 interventional study of Dietary management of seizures in Epilepsy, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-02.
Sponsored by Johns Hopkins University · Phase 3, Interventional, and Treatment
This is a prospective, open-label (no control or blind) study to continue to determine whether the modified Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults (not children) with epilepsy. This study will enroll and manage patients via email, phone, and fax and without dietitian involvement (primary difference from previous studies). It is a 3 month study.
Patients will have contacted either Dr. Kossoff or Dr. Cervenka either via referral or self-referral.
Inclusion: over 18 years of age, at least weekly seizures (or 4 per month), tried at least 2 medications for your seizures, have email and fax access, are not very underweight or have high cholesterol, have not had status epilepticus (seizure lasting over 30 minutes) in the past 6 months, and have not tried the Atkins diet before or the ketogenic diet within the past year. All patients will need to have a local primary care doctor or neurologist willing to be available in case of emergencies. You and your local physician both need to speak and write in English and patients MUST be in the United States to participate. The patient (NOT a caregiver) must be the person to email the investigators - a family member cannot be the contact person.
If the patient agrees, we will send and they will fax back within 2 weeks:
After that, we will send information on how to do the diet via email, they will maintain monthly calendars, and after 3 months we will decide if the diet is helpful. After that time point, they can continue it on their own with periodic followup with either us or their local neurologist.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Dietary management of seizures
Using the high-fat, low carbohydrate modified Atkins diet - 15 grams per day initially. This is a 3-month study of this diet.
Seizure frequency
Time frame: 3 months
Tolerability (ability to create and maintain ketosis), cholesterol, weight
Time frame: 3 months
Ability to follow instructions via email (and maintain ketosis and seizure control when achieved).
Time frame: 3 months
Ketosis (measured by urine)
Time frame: 3 months
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University