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Investigating the effect of fenofibrate for seizure control in refractory epilepsy patients

Protocol summary

Study aim
Determining the effect of fenofibrate for seizure control in refractory epilepsy patients
Design
A randomized, double-blinding clinical trial, with A single-group, Phase 2 on 30 patients
Settings and conduct
In this randomized double-blind clinical trial study, 30 eligible patients, referring to Al-Zahra and Kashani hospitals in Isfahan, will be included. For all patients, the dosage of the fenofibrate drug starts at 100 mg per day; if the seizures are not controlled, it is increased to 200 mg per day after two weeks. The intervention will be performed in such a way that the patient, the researcher, and the statistical analyst will have no knowledge of the type of intervention. Then the parameters related to seizures of the patients before and after the intervention will be compared.
Participants/Inclusion and exclusion criteria
The inclusion criteria include patients with epilepsy, age older than 18 years, resistance to at least two anticonvulsant drugs, having seizures on average twice a month or more, and consenting to participate in the study. Exclusion criteria include concurrent liver and kidney disease, hyperlipidemia, and atorvastatin drug use.
Intervention groups
In this study, only one group is treated. In this group, the dosage of the fenofibrate drug starts at 100 mg daily, and if the seizures are not controlled, it is increased to 200 mg per day after two weeks.
Main outcome variables
Number of seizure attacks, EEG changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N63
Registration date: 2023-01-17, 1401/10/27
Registration timing: prospective

Last update: 2023-01-17, 1401/10/27
Update count: 0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of fenofibrate for seizure control in refractory epilepsy patients
Public title
The effect of fenofibrate for seizure control in epilepsy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Epilepsy patients Age more than 18 years Resistant to at least two anticonvulsants Having seizures on average twice a month or more Consent to participate in the study
Exclusion criteria:
Concurrent liver and kidney disease and hyperlipidemia Atorvastatin drug use
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 30 eligible patients will be selected randomly and all will undergo a specific treatment. The present study does not have a control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, fenofibrate drug is prepared and provided to the researcher, and he prescribes it without knowing the type of drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2022-09-07, 1401/06/16
Ethics committee reference number
IR.MUI.MED.REC.1401.221

Health conditions studied

1

Description of health condition studied
Refractory epilepsy
ICD-10 code
G40.91
ICD-10 code description
Epilepsy, unspecified, intractable

Primary outcomes

1

Description
Number of seizure attacks
Timepoint
Before and after the intervention
Method of measurement
Seizure attack frequency

2

Description
EEG changes
Timepoint
Before and after the intervention
Method of measurement
Electrocardiogram (ECG)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, the dosage of fenofibrate drug starts with 100 mg daily, and if the seizures are not controlled, it is increased to 200 mg per day after two weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Mohammad Reza Najafi
Street address
Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8179964167
Phone
+98 31 3651 3337
Email
Najafi@med.mui.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
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

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Najafi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Neurology Department, Al-Zahra Hospital, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Najafi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Najafi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Neurology Department, Al-Zahra Hospital, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Najafi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Salimyan
Position
Non-faculty specialist doctor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Neurology Department, Al-Zahra Hospital, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mahsasalimyan1@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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