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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05512130
Phase
EARLY_PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 17, 2022
Status verified
Aug 2022
Primary completion
Mar 1, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin / Placebo
    Participants randomized to this arm will receive 25 mg of empagliflozin daily for 2 weeks followed placebo daily for 2 weeks
  • Experimental: Placebo / Empagliflozin
    Participants randomized to this arm will receive placebo daily for 2 weeks followed by 25 mg of empagliflozin daily for 2 weeks

Primary Outcome Measure

Change in blood beta-hydroxybutyrate while on empagliflozin [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63110
Kwee L Thio, MD, PhD
[email protected]
314-454-6120

Find similar trials in St Louis, MO

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Washington University· St Louis, MO

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