Study Summary
This trial will test whether a diabetes drug can be used to treat epilepsy in adults who haven't responded to other drugs.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 1 Secondary · Reporting Duration: 2 weeks
2 weeks
Body Weight Changes
Change in blood glucose while on empagliflozin
Seizures
Number of participants with adverse effects from empagliflozin
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Empagliflozin / Placebo
1 of 2
Placebo / Empagliflozin
1 of 2
Experimental Treatment
18 Total Participants · 2 Treatment Groups
Primary Treatment: Empagliflozin 25 mg · Has Placebo Group · Phase < 1
Empagliflozin / PlaceboExperimental Group · 2 Interventions: Empagliflozin 25 mg, Placebo · Intervention Types: Drug, Drug
Placebo / EmpagliflozinExperimental Group · 2 Interventions: Empagliflozin 25 mg, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 25 mg
2019
Completed Phase 2
~60
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,805 Previous Clinical Trials
2,278,597 Total Patients Enrolled
1 Trials studying Epilepsy
90 Patients Enrolled for Epilepsy
Kwee L ThioPrincipal InvestigatorWashington University School of Medicine
Eligibility Criteria
Age 18 - 45 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have focal, generalized, or combined generalized and focal epilepsy.
References
- Pfeifer, H. H., and E. A. Thiele. 2005. “Low-glycemic-index Treatment: A Liberalized Ketogenic Diet for Treatment of Intractable Epilepsy”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000187071.24292.9e.
- Rho, Jong M., and Raman Sankar. 2008. “The Ketogenic Diet in a Pill: Is This Possible?”. Epilepsia. Wiley. doi:10.1111/j.1528-1167.2008.01857.x.
- Kim, So Ra, Sang-Guk Lee, Soo Hyun Kim, Jin Hee Kim, Eunhye Choi, Wonhee Cho, John Hoon Rim, et al.. 2020. “SGLT2 Inhibition Modulates NLRP3 Inflammasome Activity via Ketones and Insulin in Diabetes with Cardiovascular Disease”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-020-15983-6.
- Stafstrom, Carl E., Jeffrey C. Ockuly, Lauren Murphree, Matthew T. Valley, Avtar Roopra, and Thomas P. Sutula. 2009. “Anticonvulsant and Antiepileptic Actions of 2-deoxy-d-glucose in Epilepsy Models”. Annals of Neurology. Wiley. doi:10.1002/ana.21603.
- Kossoff, E. H., G. L. Krauss, J. R. McGrogan, and J. M. Freeman. 2003. “Efficacy of the Atkins Diet as Therapy for Intractable Epilepsy”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000098889.35155.72.
- Ferrannini, Ele, Simona Baldi, Silvia Frascerra, Brenno Astiarraga, Tim Heise, Roberto Bizzotto, Andrea Mari, Thomas R. Pieber, and Elza Muscelli. 2016. “Shift to Fatty Substrate Utilization in Response to Sodium–glucose Cotransporter 2 Inhibition in Subjects Without Diabetes and Patients with Type 2 Diabetes”. Diabetes. American Diabetes Association. doi:10.2337/db15-1356.
- Biester, Torben, Olga Kordonouri, and Thomas Danne. 2019. “Beyond Type 2 Diabetes: Sodium Glucose Co‐transporter‐inhibition in Type 1 Diabetes”. Diabetes, Obesity and Metabolism. Wiley. doi:10.1111/dom.13659.
- Kossoff, Eric H., Beth A. Zupec-Kania, Stéphane Auvin, Karen R. Ballaban-Gil, A.G. Christina Bergqvist, Robyn Blackford, Jeffrey R. Buchhalter, et al.. 2018. “Optimal Clinical Management of Children Receiving Dietary Therapies for Epilepsy: Updated Recommendations of the International Ketogenic Diet Study Group”. Epilepsia Open. Wiley. doi:10.1002/epi4.12225.
- Stafstrom, Carl E., Avtar Roopra, and Thomas P. Sutula. 2008. “Seizure Suppression via Glycolysis Inhibition with 2-deoxy-d-glucose (2DG)”. Epilepsia. Wiley. doi:10.1111/j.1528-1167.2008.01848.x.
- Stafstrom CE, Roopra A, Sutula TP. Seizure suppression via glycolysis inhibition with 2-deoxy-D-glucose (2DG). Epilepsia. 2008 Nov;49 Suppl 8:97-100. doi: 10.1111/j.1528-1167.2008.01848.x.
- Rho JM, Sankar R. The ketogenic diet in a pill: is this possible? Epilepsia. 2008 Nov;49 Suppl 8(Suppl 8):127-33. doi: 10.1111/j.1528-1167.2008.01857.x.
- Biester T, Kordonouri O, Danne T. Beyond type 2 diabetes: sodium glucose co-transporter-inhibition in type 1 diabetes. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:53-61. doi: 10.1111/dom.13659.
- Pfeifer HH, Thiele EA. Low-glycemic-index treatment: a liberalized ketogenic diet for treatment of intractable epilepsy. Neurology. 2005 Dec 13;65(11):1810-2. doi: 10.1212/01.wnl.0000187071.24292.9e.
- Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91. doi: 10.1212/01.wnl.0000098889.35155.72.
- 2022. "Sodium-Glucose Cotransporter-2 Inhibitors: A Potential Novel Treatment for Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05512130.
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