NCT07180043

Propranolol for Pediatric Migraine: A Prospective Clinical Study

Clinical Predictors of Propranolol Responsiveness in Pediatric Migraine: A Prospective Observational Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Kayseri University · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Migraine is among the most common neurological disorders in children and adolescents, often leading to significant disability, reduced school performance, and impaired quality of life. Although propranolol is frequently prescribed for pediatric migraine prophylaxis, previous studies have reported heterogeneous outcomes, and clinical predictors of treatment response remain unclear. This prospective, controlled clinical trial was designed to assess the comparative effectiveness of propranolol and structured behavioral therapy in pediatric migraine patients and to identify predictors of response to propranolol. A total of 178 children, aged 6-16 years, diagnosed with primary migraine according to ICHD-3 criteria, were consecutively recruited at a tertiary pediatric neurology center between January 2021 and December 2023. Participants were allocated into two groups based on baseline Pediatric Migraine Disability Assessment (PedMIDAS) scores: Group 1 (n = 88) received structured behavioral therapy, including patient education, lifestyle guidance, and headache diary maintenance. Group 2 (n = 90) received oral propranolol at doses of 1-3 mg/kg/day for 12 weeks, with adherence monitored through logs and follow-up calls. The primary outcomes were changes in PedMIDAS and Visual Analog Scale (VAS) scores after 12 weeks. Secondary outcomes included identification of clinical, psychiatric, and biochemical predictors of treatment responsiveness. Particular attention was given to benign paroxysmal vertigo, essential tremor, anxiety traits, and micronutrient deficiencies (vitamin D and vitamin B12).

Conditions

• Pediatric Migraine
• Headache Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Structured Behavioral Therapy	Structured patient education, lifestyle modification counseling, and headache diary maintenance without pharmacological prophylaxis.
DRUG	Propranolol	Oral propranolol, 1-3 mg/kg/day in two divided doses, titrated according to response, for 12 weeks.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-01-01
• Completion: 2023-12-30
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: Turkey (Türkiye)