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Comparison the effect of Propranolol and Topiramate in Pediatric Migraine prophylaxis

Comparison the effect of Propranolol and Topiramate in Pediatric Migraine prophylaxis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201009221808N2
Enrollment
60
Registered
2010-10-23
Start date
2010-08-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Migraine. Migraine without aura [common migraine]

Interventions

Intervention 1: In Intervention Group: Topiramate 2mg/kg/day in 2 divided dose ( oral ). Intervention 2: In Control Group : Propranolol 0.5-1mg/kg/day in 2 divided dose ( oral ).
Treatment - Drugs
In Intervention Group: Topiramate 2mg/kg/day in 2 divided dose ( oral )
In Control Group : Propranolol 0.5-1mg/kg/day in 2 divided dose ( oral )

Sponsors

Research Center of Mazandaran University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1- Age between 5-15 yr 2- Patient with Common Migraine IHS criteria 3- History of Headache in last 6months 4- No Drug history of Propranolol or Topiromate 5- Discontinuation of other prophylactic drugs one month prior to study 6- At least 2 episode of Migraine Headache in one month. Exclusion Criteria: 1- Contraindications of Propranolol or Topiromate in pre-existing Disease 2- Patient with Epilepsy or Movement Disorders 3- Patient who don’t follow up their Treatment 4- Appearing of drug side effects.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Number of Migraine Headache episode. Timepoint: Before intervention, 4 & 8 weeks after intervention. Method of measurement: Questionnarie.

Secondary

MeasureTime frame
Nausea & Vomiting. Timepoint: 4 & 8 weeks after beginning of treatment. Method of measurement: Questionnaire.;Weight loss. Timepoint: 4 & 8 weeks after beginning of treatment. Method of measurement: Questionnaire.;Drowsiness. Timepoint: 4 & 8 weeks after beginning of treatment. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Abbaskhanian

Mazandaran University of Medical Sciences and Health Services

aabbaskhanian@mazums.ac.ir+98 15 1223 3013

Outcome results

None listed

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