Catamenial Epilepsy, Epilepsy, Medically Resistant Epilepsy, Medically Resistant Seizures, Seizure
Conditions
Keywords
seizures, epilepsy, catamenial, ketogenic diet, modified Atkins diet, intractable epilepsy, medically refractory epilepsy, adult, medium chain triglyceride
Brief summary
The modified Atkins diet (MAD) has been shown to be effective in treating intractable epilepsy. Approximately 55% of the patients started on the diet are women of childbearing age and women with epilepsy often have a pattern of seizures that correlates with their menstrual cycle, called catamenial epilepsy. The investigators have observed that despite an overall reduction in seizure frequency, some women on the MAD continue to have breakthrough seizures in a catamenial pattern. The investigators hypothesize that women with a history of intractable epilepsy who have been on the modified Atkins diet for at least 3 months and have a catamenial seizure pattern will tolerate and be compliant with the addition of a daily amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.
Interventions
DIETARY_SUPPLEMENTbetaquik®
Participants will add betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.
Sponsors
Vitaflo International, Ltd
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women ≥ 18 years * Already on the modified Atkins diet for at least 3 months and compliant with treatment * Catamenial seizure pattern (by Herzog criteria) for at least 2 of the past 3 months (as documented by calendars provided with annotations for seizures and menstrual cycle start and end dates)
Exclusion criteria
(basic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months | 6 months | The primary outcome measure will be compliance with betaquik® (compared to published compliance of MAD and medium chain triglyceride diets) to demonstrate feasibility. The participant will be considered compliant if they drink the required amount of betaquik® on more than 80% of the prescribed days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability (10 point tolerance scale) | 6 months | Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale. |
Countries
United States
Outcome results
None listed