Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy

Completed · Phase 3

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00436631

Run by

Johns Hopkins University

People needed

30

Starts

2007-02-01

Expected to finish

2011-12-01

Last updated by the study team

2015-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older.
• Patients must consent for themselves (NOT a family member doing this).
• Patients need to be willing to perform the induction phase of the diet.
• Patients must have access to an email account and fax machine.
• Persisting, countable seizures (> 1 per week or 4 times per month) despite previous treatment with two or more antiepileptic drugs.
• Patients with coronary heart disease, cerebrovascular disease, peripheral vascular disease, atherosclerosis, prior myocardial infarctions, or renal dysfunction will be excluded.

You may not qualify if…

• Patients previously exposed to the Atkins diet (for more than one week) will be excluded.
• Patients who had tried the ketogenic diet within the past year will be excluded.
• Patients with non-epileptic seizures (pseudoseizures) will be excluded.
• Patients that are pregnant or become pregnant during the study will be excluded.
• Patients must have a local English-speaking neurologist or primary care provider willing to sign a form stating they are available for any emergencies, considering some patients may be a far distance away.
• Patients must live in the United States.
• Patients must not have a history of status epilepticus within the past 6 months.
• Patients with a BMI that is below 18.5 will be excluded.
• Patients must speak and write in English.
• Patients must be from the United States.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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