NCT07103031

Comorbidity-Based Propranolol Use in Pediatric Migraine

Targeting The Right Pediatric Migraine Patient: A Comorbidity-Oriented Approach To Propranolol Prophylaxis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 488 (actual)
• Sponsor: Kayseri University · Academic / Other
• Sex: All
• Age: 2 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

This observational retrospective cohort study aims to identify clinical and biochemical predictors of response to propranolol prophylaxis in pediatric migraine. A total of 178 children diagnosed with migraine between 2021 and 2023 were evaluated based on headache-related disability (PedMIDAS) and pain severity (VAS). Patients were treated either with behavioral therapy or propranolol (1-3 mg/kg/day) for 3 months.

Detailed description

Migraine is a common and disabling neurological condition in the pediatric population, often requiring prophylactic treatment to reduce attack frequency and improve quality of life. Propranolol is frequently prescribed for pediatric migraine prevention; however, treatment response varies considerably among individuals. Understanding the clinical and biochemical factors that predict treatment efficacy could enhance individualized care and reduce unnecessary medication use. This retrospective cohort study evaluated 178 children diagnosed with pediatric migraine between January 2021 and December 2023 at a tertiary neurology outpatient clinic. All participants were assessed using the Pediatric Migraine Disability Assessment Scale (PedMIDAS) and Visual Analog Scale (VAS) before and after treatment. Patients received either behavioral therapy or oral propranolol (1-3 mg/kg/day) for a duration of 3 months, based on clinical indication and family preference.

Conditions

• Pediatric Migraine
• Migraine Disorders, Brain
• Vitamin D Deficiency

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral therapy	Patients in PedMIDAS stage 1-2 (score ≤ 30) received behavioral therapy including lifestyle counseling, stress management techniques, sleep hygiene education, and individualized headache triggers review. Additionally, each patient was provided with a headache report card to self-monitor symptoms, triggers, and medication use over a 3-month period.
DRUG	Propranolol	Patients in PedMIDAS stage 3-4 (score \> 30) received oral propranolol treatment at a dose of 1-3 mg/kg/day, adjusted by weight and tolerance, for a total of 3 months. The medication was prescribed and monitored by a pediatric neurologist. Patients were followed with routine check-ups and adverse effects were recorded.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2025-08-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: Turkey (Türkiye)