Propranolol for Pediatric Migraine: A Prospective Clinical Study

NCT07180043 | Completed

• 2 other identifiers: KayseriUniversityEC/IRB Number
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Migraine; Headache Disorders

Keywords

Pediatric Migraine; Propranolol; Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score

  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.

  Baseline and Week 12

• Change in Visual Analog Scale (VAS) Pain Score

  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.

  Baseline and Week 12

Secondary Outcomes (1)

• Responder Rate

  Week 12

Study Arms (2)

Structured Behavioral Therapy

OTHER

Participants received structured behavioral therapy including patient education, lifestyle guidance, and maintenance of a headache diary, without pharmacological prophylaxis.

Behavioral: Structured Behavioral Therapy

Propranolol

EXPERIMENTAL

Participants received oral propranolol at 1-3 mg/kg/day in two divided doses for 12 weeks. Dose titration was performed based on clinical response and tolerance.

Drug: Propranolol

Interventions

Structured Behavioral Therapy BEHAVIORAL

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

Structured Behavioral Therapy

Propranolol DRUG

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

Propranolol

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri University: lead

Study Sites (1)

Kayseri University

Kayseri, Kayseri, 38130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache Disorders

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 18, 2025
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: December 30, 2023
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)