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NCT Number: NCT07103031

Comorbidity-Based Propranolol Use in Pediatric Migraine

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.

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Key information

Conditions

Pediatric Migraine Avitaminosis Brain Diseases Central Nervous System Diseases Deficiency Diseases Headache Disorders Headache Disorders, Primary Malnutrition Migraine Disorders Migraine Disorders, Brain Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

2 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kayseri University

Kayseri, 38130, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral therapy

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.

Other names: Cognitive-Behavioral Therapy

Propranolol

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.

Other names: β-blocker

Primary outcomes

  1. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score

    Time frame: 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 outcomes

  1. Visual Analog Scale (VAS) Pain Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kayseri University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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