Recruiting
Early Phase 1

SGLT2 Inhibitors

Sponsor:

Washington University School of Medicine

Code:

NCT05512130

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 25 mg

Placebo

Study Details

Brief 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.

Conditions

Epilepsy

Study ID

NCT05512130

Start date

Aug 17, 2022

Status verified date

Aug, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Mar 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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%

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Empagliflozin 25 mg

Participants will take empagliflozin daily for 2 weeks.

Placebo

Participants will take a placebo daily for 2 weeks. The placebo will be identical to empagliflozin in appearance.

Primary outcome measure

  • Change in blood beta-hydroxybutyrate while on empagliflozin [ Time Frame: 2 weeks ]
  • Change in blood glucose while on empagliflozin [ Time Frame: 2 weeks ]
  • Number of participants with adverse effects from empagliflozin [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Kwee L Thio, MD, PhD

314-454-6120thiol@wustl.edu

Locations

Washington University

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Kwee L Thio, MD, PhD

314-454-6120thiol@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 23, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2022-08-23.