Comorbidity-Based Propranolol Use in Pediatric Migraine

NCT ID: NCT07103031

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 488 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Pediatric Migraine; Migraine Disorders, Brain; Vitamin D Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1

Behavioral therapy group

Behavioral therapy

Intervention Type: BEHAVIORAL

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.

Group 2

Propranolol group

Propranolol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Other Intervention Names

Cognitive-Behavioral Therapy; β-blocker

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kayseri University

OTHER

Sponsor Role: lead

Responsible Party

Özge BAYKAN ÇOPUROĞLU

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kayseri University

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EC/IRB Number- 2021/12-14

Identifier Type: OTHER

Identifier Source: secondary_id

KayseriUniversity12

Identifier Type: -

Identifier Source: org_study_id