drugset / Trial / NCT07180043

Propranolol for Pediatric Migraine: A Prospective Clinical Study

NCT07180043

Completed 178 enrolled Kayseri University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This prospective, controlled clinical trial was conducted to evaluate the effectiveness of propranolol compared with structured behavioral therapy in pediatric patients diagnosed with primary migraine according to ICHD-3 criteria. A total of 178 children aged 6 to 16 years were enrolled between January 2021 and December 2023 at a tertiary pediatric neurology center. Participants were allocated into two groups based on baseline Pediatric Migraine Disability Assessment (PedMIDAS) scores: Group 1 received standardized behavioral therapy, while Group 2 received propranolol at doses ranging from 1-3 mg/kg/day for 12 weeks. Primary outcomes included changes in PedMIDAS and Visual Analog Scale (VAS) scores. Secondary analyses investigated clinical and biochemical predictors of propranolol responsiveness, including benign paroxysmal vertigo, essential tremor, anxiety, vitamin D status, and vitamin B12 levels. The study aims to provide evidence for a more personalized approach to migraine prophylaxis in children by integrating clinical, psychiatric, and nutritional predictors of treatment response.

Timeline

Start
2021-01-01
Primary completion
2023-01-01
Completion
2023-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Propranolol Small molecule 1 mg/kg Oral
Subject Propranolol Small molecule 3 mg/kg Oral

Indications