Protocol summary
-
Study aim
-
To evaluate the therapeutic value of Empagliflozin which is an SGLT2 inhibitor, on drug-resistant epilepsy patients.
-
Design
-
This study is a phase 3 clinical trial, containing 2 parallel groups ( a group with 25 mg of drug and another group with placebo) with complete randomization created by sealedenvelope site and double-blind. Each group includes 35 patients.
-
Settings and conduct
-
The study is going to be conducted in the Neuroscience Research Center of Tehran Imam Khomeini Hospital. Patients of the hospital are entered into the 3-month follow-up study with their consent after checking for including and excluding criteria. Patients are aware of randomization but in the end, all patients and all the researchers including those who gather data and those who take care of patients except the data analyst, are blind. Data is gathered by using a special code for each patient.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
1. Patients who have drug-resistant epilepsy and have tried two insufficient and different medical treatment
2. Age between 18 to 45
Exclusion criteria:
1. Other neurological disorders
2. Metabolic disorders
3. Dyslipidemia
4. Kidney diseases
5. Active infection
6. The patient refuses to continue the study
7. Showing the unregistered side effects of drug
8. BMI more than 30 and less than 18.5
9. Non-compliant patients
10. Pregnancy
11. Patients with ketogenic diet
12. Patients with carbonic anhydrase inhibitor medication
-
Intervention groups
-
Placebo group: taking 1 tablet each day for 3 months
Drug group: taking 1 tablet of Empagliflozin each day for 3 months, dose: 25 mg
-
Main outcome variables
-
Reducing the seizure frequency of patients; Reducing the severity of patients' seizures
General information
-
Reason for update
-
More accurate sample size was assessed by a more proffesional methodologist. Also because of the problem facing pharmaceutical comany, the preparation of the drug and placebo was postpone. Thus the start of the project was postpone.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20230813059134N1
Registration date:
2023-09-18, 1402/06/27
Registration timing:
prospective
Last update:
2024-07-30, 1403/05/09
Update count:
1
-
Registration date
-
2023-09-18, 1402/06/27
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2024-03-15, 1402/12/25
-
Expected recruitment end date
-
2025-03-15, 1403/12/25
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
the effect of empagliflozin on control of seizure attacks in patients with drug-resistance epilepsy
-
Public title
-
Empagliflozin and drug-resistant epilepsy
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
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
-
Age
-
From 18 years old to 45 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
50
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Complete randomization is done by considering each individual as a unit. Randomization is created by sealedenvelope site, and allocation is concealed by using a special code for each case.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
With the previous explanation about the placebo and drug group, patients are blinded about their group. Also, all of the team researchers and people in contact with the patients, including those who gather the data, are blind and they only use a special code for each patient to access their data.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2023-08-29, 1402/06/07
-
Ethics committee reference number
-
IR.TUMS.IKHC.REC.1402.204
Health conditions studied
1
-
Description of health condition studied
-
Epilepsy
-
ICD-10 code
-
G40
-
ICD-10 code description
-
Epilepsy and recurrent seizures
Primary outcomes
1
-
Description
-
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
2
-
Description
-
Seizure severity
-
Timepoint
-
Baseline, 30 days, and 90 days after starting the drug/placebo
-
Method of measurement
-
Evaluating the seizure diary
Secondary outcomes
1
-
Description
-
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
Intervention groups
1
-
Description
-
Intervention group: Patients in this group take one Empagliflozin pill per day with dosage of 25 mg, for 3 months.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Patients in this gruop take one placebo pill per day, for 3 months.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Neuroscience Research Center of Imam Khomeini hospital
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available