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Efficacy of topiramate and topiramate with omega-3 fatty acid in prophylaxis of children migraine headaches

Evaluation of efficacy of topiramate alone and topiramate with omega-3 fatty acid in prophylaxis of headaches in 5-15 year old children with migraine

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091027002639N23
Enrollment
60
Registered
2020-03-31
Start date
2019-03-07
Completion date
Unknown
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine headache. Migraine

Interventions

Intervention 1: Control group: Tablet of 25 and 50 mg of topiramate of Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose for two months. Intervention 2: Intervention group: One daily capsule o

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years

Inclusion criteria

Inclusion criteria: children aged 5-15 years old having migraine headache based on International Headache Society Criteria having one or more headache attack per week having moderate or severe headache disability have not received omega-3 combinations within the past two months did not use any migraine preventive therapy

Exclusion criteria

Exclusion criteria: secondary headaches such as epilepsy or other neurologic disorders allergy to topiramat or omega-3 discontinuation of drugs usage for more than one week irregullar drugs usage

Design outcomes

Primary

MeasureTime frame
Monthly frequency of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Severity of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Duration of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Pediatric Migraine Disability score. Timepoint: Before and two months after treatment. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Clinical side effects. Timepoint: Before and two months after treatment. Method of measurement: Clinical exam and asking from patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Razieh Fallah

Yazd University of Medical Sciences

FALLAH@ssu.ac.ir+93 53 822 4000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026