Comorbidity-Based Propranolol Use in Pediatric Migraine

Completed

• Conditions: Pediatric Migraine; Migraine Disorders, Brain; Vitamin D Deficiency
• Interventions: Behavioral: Behavioral therapy; Drug: Propranolol

• Registration Number: NCT07103031
• Lead Sponsor: Kayseri University

Brief 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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

• Children aged 0-20 years
• Diagnosed with primary headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
• Clinical and/or neurological evaluation consistent with primary headache
• Completed baseline PedMIDAS and VAS assessments
• Available for 3-month follow-up after initiation of treatment

Exclusion Criteria

• Diagnosis of secondary headache, based on clinical history, family history, neurological examination, or laboratory/imaging findings
• Failure to meet ICHD-3 diagnostic criteria for primary headache
• Presence of structural brain lesions or other neurological disorders
• Chronic systemic illness or current use of other migraine prophylactic medications
• Incomplete data or loss to follow-up within the 3-month period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Behavioral therapy	Behavioral therapy group
Group 2	Propranolol	Propranolol group

Primary Outcome Measures

Name	Time	Method
Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score	Baseline to 3 months after treatment	The primary outcome is the change in PedMIDAS score from baseline to 3 months after treatment. PedMIDAS is a validated questionnaire that quantifies migraine-related disability in children and adolescents. A greater reduction indicates improved clinical response.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Scores	Baseline to 3 months after treatment	VAS pain scores range from 0 (no pain) to 10 (worst imaginable pain). The change in VAS score after 3 months of treatment reflects the patient's subjective pain improvement.

Trial Locations

Locations (1)

Kayseri University; 🇹🇷 Kayseri, Turkey