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Sodium-Glucose Cotransporter-2 Inhibitors: A Potential Novel Treatment for Epilepsy
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 Start (Actual) 17 August 2022
🗓️ Primary Completion (Estimated) 1 March 2023
✅ Study Completion (Estimated) 30 June 2023
👥 Enrollment (Estimated) 18
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

    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%
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 July 2022
  • First Submitted that Met QC Criteria 20 August 2022
  • First Posted 23 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 August 2022
  • Last Update Posted 23 August 2022
  • Last Verified August 2022
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