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
This study is a single arm open label quasi-experimental clinical trial (before and after) in which ten patients will be compared regarding seizures frequency before and after treatment.
Settings and conduct
Primary and secondary consequences will be evaluated in the TUMS epilepsy centers patients. The primary consequences are the seizures frequency and life quality, and any other treatments side effects will be considered as secondary consequences. In case of dissatisfaction of the participant and patient's guardian or the occurrence of life-threatening complications, the patient will be excluded from the study. All information is entered into SPSS software and the effectiveness of the drug on the desired initial outcome: reduction of seizure frequency to 30 percent compared to before receiving the drug and other consequences in patients are statistically analyzed.
Frequent measurement of variables: To report quantitative variables, if the data is normal, the mean and standard deviation will be used, and if the normality is not established, the mean and amplitude will be used. If the normality hypothesis is established, the analysis of variance test for repeated measures (ANOVA) will be used, otherwise the Friedman test will be replaced. The McNemar test will also be used to examine the relationship between qualitative variables. Using spss software will run at 5% error level.
Participants/Inclusion and exclusion criteria
Inclusion criteria is over 6 years patients with Dravet syndrome and with a minimum seizure frequency of 6 seizures per month
Intervention groups
8mg/day Ramelteon tablet divided into two 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:IRCT20220105053639N1
Registration date:2022-04-19, 1401/01/30
Registration timing:prospective
Last update:2022-04-19, 1401/01/30
Update count:0
Registration date
2022-04-19, 1401/01/30
Registrant information
Name
Mahmoud Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6147 2751
Email address
mahmoh365@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-05-15, 1401/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Ramelteon in pharmacoresistant patients with Dravet syndrome aged more than 6 years in the pediatric epileptic centers in seizures control
Public title
Efficacy of Ramelteon in pharmacoresistant patients with Dravet syndrome aged more than 6 years in the pediatric epileptic centers in seizures control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum seizure frequency should be 6 seizures per month
Minimum age should be 6 years old
Exclusion criteria:
If the patient can not swallow the tablet.
Age
From 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
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
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
2021-12-29, 1400/10/08
Ethics committee reference number
IR.TUMS.CHMC.REC.1400.203
Health conditions studied
1
Description of health condition studied
Dravet Syndrome
ICD-10 code
G40.83
ICD-10 code description
Polymorphic epilepsy in infancy (PMEI)
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 treatment
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Any outcome other than reducing the frequency of seizures and improving the quality of treatment (side effect) is considered a secondary consequence.
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
Intervention groups
1
Description
Intervention group: Ten patients with Dravet syndrom with Ramelteon treatment by the dose of 8 mg/day orally divided into two 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
Fax
+98 21 6693 0024
Email
hosseinpour.sare@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Theracule AS
Full name of responsible person
Elham Shojaeinia
Street address
Oslo Science Park Gaustadalleen 21 0349 Oslo
City
Oslo
Postal code
0349
Phone
+47 948 36 983
Fax
Email
elham@theracule.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Theracule AS
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
NO
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
Fax
+98 21 6693 0024
Email
hosseinpour.sare@gmail.com
Web page address
https://chmc.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoud Mohammdi
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
Fax
+98 21 6693 0024
Email
mahmoh365@yahoo.com
Web page address
https://chmc.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
Fax
+98 21 6693 0024
Email
hosseinpour.sare@gmail.com
Web page address
https://chmc.tums.ac.ir/
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