Skip to main content
OpenTrials
Completed

NCT Number: NCT07180043

Propranolol for Pediatric Migraine: A Prospective Clinical Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pediatric Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Nervous System Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri University

Kayseri, 38130, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of primary migraine (with or without aura) according to ICHD-3 criteria
  • Age between 6 and 16 years
  • Minimum of 4 migraine attacks per month
  • No history of prophylactic migraine therapy within the last 3 months
  • Written informed consent obtained from parents or legal guardians

Exclusion criteria

  • Secondary headaches due to underlying pathologies (e.g., tumors, infections, vascular malformations)
  • Chronic systemic or psychiatric disorders (e.g., epilepsy, major depression)
  • Contraindications to propranolol (e.g., asthma, cardiac conduction defects)
  • Incomplete clinical data or loss to follow-up

Treatment and study plan

Structured Behavioral Therapy

Behavioral

Structured patient education, lifestyle modification counseling, and headache diary maintenance without pharmacological prophylaxis.

Propranolol

Drug

Oral propranolol, 1-3 mg/kg/day in two divided doses, titrated according to response, for 12 weeks.

Primary outcomes

  1. Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score

    Time frame: Baseline and Week 12

    Change in PedMIDAS score from baseline to 12 weeks, assessing migraine-related disability in pediatric patients. The PedMIDAS score ranges from 0 to 240, with higher scores indicating greater migraine-related disability. Lower scores reflect less disability and therefore a better outcome.

  2. Change in Visual Analog Scale (VAS) Pain Score

    Time frame: Baseline and Week 12

    Change in VAS pain intensity score from baseline to 12 weeks, evaluating migraine pain severity. The VAS score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain severity, while lower scores indicate improvement.

Secondary outcomes

  1. Responder Rate

    Time frame: Week 12

    Proportion of participants achieving ≥50% reduction in monthly migraine frequency compared with baseline.

Sponsors and collaborators

Lead sponsor

Kayseri University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2025
Registry last updated
Sep 18, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.