Status:
UNKNOWN
Efficacy and Safety of Ketogenic Diet as Adjunctive Treatment in Adults With Refractory Epilepsy
Lead Sponsor:
Mid-Atlantic Epilepsy and Sleep Center, LLC
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to obtain pilot data on safety and efficacy of ketogenic diet (KD) as adjunctive treatment of adults with refractory epilepsy. This will be an open label study comparing se...
Detailed Description
The goal of the present open label study is to obtain pilot data to evaluate the efficacy and safety of KD in adults with intractable epilepsy. Investigators will evaluate the effect of KD on seizure ...
Eligibility Criteria
Inclusion
- Age 18-65
- Stable epilepsy, either primary generalized or localization-related with partial complex seizures including partial complex seizures with or without secondary generalization, partial simple seizures with a clear motor component with or without secondary generalization, and partial simple seizures with secondary generalization; primary generalized tonic clonic seizures; and absence seizures of \> 10 sec duration.
- Stable AED doses for at least 30 days
- Epilepsy duration for \> 1 year
- Past/current treatment with \> 3 AEDs. Vagal nerve stimulation treatment will be allowed and will not count as an AED. Vagal nerve stimulation setting must be stable for 3 months prior to enrollment
- Seizure frequency of \> 0.5/month
Exclusion
- Exclusively myoclonic seizures or absence seizures of ≤ 10 sec duration; simple partial seizures without motor components or secondary generalization
- Non-epileptic seizures
- Progressive neurological disease including neoplasm, central nerve system degenerative disorders including Alzheimer's disease, other forms of dementia
- Any systemic illness or unstable medical condition that might pose additional risk, including: renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, other unstable metabolic or endocrine disturbances, and active systemic cancer
- Familial hyperlipidemia or uncontrolled hyperlipidemia
- Body Mass Index (BMI) \< 18
- Change in the dose of any Antiepileptic Drug within 30 days prior to enrollment
- Psychosis within six months of enrollment.
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
- Pregnancy
- Use of any CNS-active investigational drugs within 3 months of enrollment.
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01906398
Start Date
January 1 2013
End Date
December 1 2018
Last Update
February 23 2018
Active Locations (1)
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1
MidAtlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817