In this study, which is to be designed as a clinical trial, the effect of a repurposed drug will be investigated on seizure frequency and quality of life in these patients.
Design
his study is a single arm open label quasi-experimental clinical trial (before and after) in which twenty patients will be compared regarding seizures frequency before and after treatment.
Settings and conduct
20 patients with treatment-resistant genetic epilepsy syndromes from the epilepsy centers of Tehran University of Medical Sciences, over 5 years of age, who meet the inclusion criteria, were selected and randomly divided into two groups to receive two doses of 8 and 1 mg. per day of Remiltion tablets divided into four meals per day for three months. This study is a semi-experimental (before and after) single arm open label clinical trial study and the patients are compared with the amount of seizures before the start of treatment in terms of seizure control.
Participants/Inclusion and exclusion criteria
Inclusion criteria is over 5 years patients with drug resistance genetic epilepsy
syndromes and with a minimum seizure frequency of 20 seizures per month
Intervention groups
Ramelteon tablet (8mg/day and 1mg/day divided into four parts) will be used orally for tree months.
Main outcome variables
Seizure frequency reduction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110628006907N19
Registration date:2023-12-01, 1402/09/10
Registration timing:prospective
Last update:2023-12-01, 1402/09/10
Update count:0
Registration date
2023-12-01, 1402/09/10
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Rameleteon in pediatrics and adolescent patients aged more than 5 years with drug resistancegenetic epilepsy syndromes
Public title
Efficacy of Rameleteon in pediatrics and adolescent patients aged more than 5 years with drug resistancegenetic epilepsy syndromes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum seizure frequency should be 20 seizures per month
Minimum age should be 5 years old
Exclusion criteria:
If the patient can not swallow the tablet.
Age
From 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences, medical faculty, ethics in research commi
Street address
Office of the Vice Chancellor for Research, First Floor, Building No. 1 of the Faculty of Medicine, Poursina St. North Door of the University, Ghods St, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2023-09-05, 1402/06/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.322
Health conditions studied
1
Description of health condition studied
Drug resistance genetic epilepsy syndromes
ICD-10 code
G40.3
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes
Primary outcomes
1
Description
Seizure frequency
Timepoint
Measurement of seizure frequency one month before the study (before the intervention) and 1, 2 and 3 months after the start of Remeltion
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Decreased quality of life caused by treatment
Timepoint
Measuring the quality of life one month before the study (before the start of the intervention) and 1, 2 and 3 months after the start of Rameltion
Method of measurement
Questionnaire
2
Description
Emergence of new types of seizures in patients
Timepoint
Measuring the quality of life one month before the study (before the start of the intervention) and 1, 2 and 3 months after the start of Rameltion
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Twenty patients with drug resistance genetic epilepsy syndromes with Ramelteon treatment by the dose of 1 and 8 mg/day orally divided into four parts for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Epilepsy centers of Tehran University of Medical Sciences
Full name of responsible person
Sareh Hosseinpour
Street address
No. 62, Pediatric Medical Center, Dr. Gharib street
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
hosseinpour.sare@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Institute for Orphan Drug Discovery
Full name of responsible person
Elham Shojaeinia
Street address
Stresemannstrasse 46
City
Bremerhaven
Postal code
27570
Phone
+49 35262 1163034
Email
contact.iodd@protonmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute for Orphan Drug Discovery
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
DE
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sareh Hosseinpour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
hosseinpour.sare@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoodreza Ashrafi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
ashrafim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sareh Hosseinpour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
hosseinpour.sare@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Pending
When the data will become available and for how long
Pending
To whom data/document is available
Pending
Under which criteria data/document could be used
Pending
From where data/document is obtainable
Pending
What processes are involved for a request to access data/document