1. Home
  2. Approved trials
  3. » فارسی

Comparison of the therapeutic effects of using single-dose and twice-daily topiramate for migraine prophylaxis in children aged 5 to 18 years referred to Tehran Children's Medical Center Hospital

Protocol summary

Study aim
Evaluation of the effectiveness of single-dose and twice-daily topiramate in reducing the severity, duration, and frequency of migraine attacks in children referred to Tehran Children's Medical Center Hospital
Design
Randomized controlled clinical trial with parallel groups on 70 patients. Randomization is done using Block Randomization.
Settings and conduct
In Patients referred to the Children's Medical Center in Tehran, demographic findings, assessment of the effectiveness of the drug in prophylaxis, frequency and severity of attacks, duration of migraine attacks, disability due to migraine, and side effects of the drug used will be asked and noted in the patient's clinic file. Symptoms related to the severity, frequency, and duration of headaches will be recorded every 3 months during periodic patient visits.
Participants/Inclusion and exclusion criteria
the inclusion criteria encompassed children aged 5 to 18 years diagnosed with migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), candidates for prophylactic treatment with a minimum of two migraine attacks per month, and informed consent obtained from their parents or legal guardians. Exclusion criteria included the presence of other systemic diseases, use of medications for migraine prevention in the past three months, known hypersensitivity to topiramate, and inability to adhere to regular follow-up assessments.
Intervention groups
۷۰ بیمار مبتلا به بیماری میگرن در طول ۶ ماه مورد مطالعه قرار میگیرند. این بیماران به صورت تصادفی به دو گروه ۳۵ نفری تقسیم می شوند و برای دسته اول داروی توپیرامات به صورت تک دوز و برای دسته دوم داروی توپیرامات به صورت دو دوز در روز (BD) تجویز می گردد. این بیماران تحت درمان پروفیلاکسی با توپیرامات با دوز ۲mg/kg/day ماکزیموم دوز ۱۰۰ میلی گرم در روز قرار خواهند گرفت.
Main outcome variables
Severity, frequency, duration, and headache-related disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250508065645N1
Registration date: 2025-05-16, 1404/02/26
Registration timing: prospective

Last update: 2025-05-16, 1404/02/26
Update count: 0
Registration date
2025-05-16, 1404/02/26
Registrant information
Name
Sina Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2238 1781
Email address
sina_fth74@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-22, 1404/04/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effects of using single-dose and twice-daily topiramate for migraine prophylaxis in children aged 5 to 18 years referred to Tehran Children's Medical Center Hospital
Public title
Single-dose topiramate in migraine prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria for the study are children aged 5 to 18 years diagnosed with migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) , candidates for prophylactic treatment who experienced a minimum of two migraine attacks per month , and obtained informed consent from their parents or legal guardians to participate in the study
Exclusion criteria:
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study randomization was employed to randomly assign participants to treatment groups. This method aids in maintaining group balance and controlling confounding variables by dividing participants into homogeneous blocks and randomizing within each block
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
461884513
Approval date
2025-04-19, 1404/01/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.045

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
Headache frequency, headache severity, headache duration, headache-related disability, side effects
Timepoint
At the beginning of the study, 3 months and 6 months after taking the medication
Method of measurement
History, Verbal Pain Scale, Visual Analogue Scale, Pediatric Migraine Disability Assessment (PedMIDAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the present study the calculated therapeutic dose of topiramate for pediatric patients was based on guidelines from the American Academy of Neurology (AAN) and the American Headache Society (AHS), which recommend a dose of 2 mg/kg/day with a maximum of 100 mg/day. Topiramate was initiated at a dose of 1 mg/kg/day for participants and, if necessary, titrated according to a predefined schedule to reach the optimal dose.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز طبی کودکان تهران
Full name of responsible person
Dr Mahmoudreza Ashrafi
Street address
No. 62. , Dr Gharib St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9999
Email
cmcpr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ramin Kordi
Street address
Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sina Fathi
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Koohestan St. , Farahzadi Blvd.
City
Tehran
Province
Tehran
Postal code
1981655715
Phone
+98 21 2238 1781
Fax
Email
sina_fth74@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sina Fathi
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Koohestan St. , Farahzadi Blvd.
City
Tehran
Province
Tehran
Postal code
1981655715
Phone
+98 21 2238 1781
Fax
Email
sina_fth74@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sina Fathi
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Koohestan St. , Farahzadi Blvd.
City
Tehran
Province
Tehran
Postal code
1981655715
Phone
+98 21 2238 1781
Fax
Email
sina_fth74@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...