Sodium-Glucose Cotransporter-2 Inhibitors: A Potential Novel Treatment for Epilepsy

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

About 30% of persons with epilepsy have seizures that do not respond to drugs. The ketogenic diet is an effective treatment option for them, but this high fat diet is strict and difficult to maintain. The properties of gliflozins, which often are used to treat type 2 diabetes, make them a potential replacement for the ketogenic diet. This pilot study will determine whether gliflozins induce ketosis and could be used to treat adults with epilepsy safely.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Age 18-45 years

• Focal, generalized, combined generalized and focal, or unknown epilepsy type

• Drug-responsive or drug-resistant epilepsy

Exclusion Criteria:

• Seizure frequency >2 seizures per day during the 6 months prior to enrollment

• Status epilepticus during the 2 years prior to enrollment

• Taking a gliflozin

• Allergy to gliflozins

• Taking a carbonic anhydrase inhibitor such as acetazolamide

• On any ketogenic diet variant

• Having an absolute contraindication to a ketogenic diet

• Type 1 or type 2 diabetes

• Pregnancy

• Moderate to severe intellectual disability,

• Significant cardiovascular disease

• Renal insufficiency

• Body mass index <18.5 or ≥30

• Hemoglobin A1c ≥5.7%