NCT05512130

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The 30% of persons with epilepsy who are drug-resistant bear most of the financial and psychosocial costs of this common neurological disorder. An effective, clinically used treatment for these individuals is the ketogenic diet, a high fat, low carbohydrate diet. Newer variants of the ketogenic diet including the modified Atkins diet (MAD) and low glycemic index treatment (LGIT) are more palatable than the older versions but are challenging to maintain because they are strict. The MAD and LGIT lower blood glucose and produce mild ketosis. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) such as empagliflozin have become important additions to the armamentarium for treating type 2 diabetes. SGLT2i decrease blood sugar by causing glucosuria, and they induce mild ketosis. These actions raise the possibility that SGLT2i can replace the MAD and LGIT as epilepsy treatments. This pilot, phase 1 study will determine the feasibility, safety, and tolerability of the SGLT2i empagliflozin in adults with epilepsy.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Empagliflozin 25 mg	Participants will take empagliflozin daily for 2 weeks.
DRUG	Placebo	Participants will take a placebo daily for 2 weeks. The placebo will be identical to empagliflozin in appearance.

Timeline

• Start date: 2022-08-17
• Primary completion: 2023-03-01
• Completion: 2023-06-30
• First posted: 2022-08-23
• Last updated: 2022-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study