Status:
COMPLETED
Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
Lead Sponsor:
Johns Hopkins University
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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 medi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00436631
Start Date
February 1 2007
End Date
December 1 2011
Last Update
September 2 2015
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287