Empagliflozin and drug-resistant epilepsy
Phase 3
Recruiting
- Conditions
- Epilepsy.Epilepsy and recurrent seizures
- Registration Number
- IRCT20230813059134N1
- Lead Sponsor
- euroscience Research Center of Imam Khomeini hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Patients who have drug-resistant epilepsy and have tried two insufficient and different medical treatment
Age between 18 to 45
Exclusion Criteria
Other neurological disorders
Metabolic disorders
Dyslipidemia
Kidney diseases
Active infection
Patient refuse to continue the study
Showing the unregistered side effects of drug
BMI more than 30 and less than 18.5
Non- compliant patients
Pregnancy
Patients with ketogenic diet
Patients with carbonic anhydrase inhibitor medication
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seizure frequnecies. Timepoint: Baseline, 30 days, and 90 days after starting the drug/placebo. Method of measurement: Daily calendar of the patients relating to their convulsions.;Seizure severity. Timepoint: Baseline, 30 days, and 90 days after starting the drug/placebo. Method of measurement: Evaluating the seizure diary.
- Secondary Outcome Measures
Name Time Method Blood sugar, A1C, lipid profile, serum electrolytes ( K, Na, P, Ca ), VBG, urine analysis, CBC. Timepoint: Baseline, 30 days, and 90 days after starting the drug/placebo. Method of measurement: Laboratory kits.