Propranolol for Pediatric Migraine: A Prospective Clinical Study

NCT ID: NCT07180043

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-12-30

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.

Detailed Description

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).

Conditions

Pediatric Migraine; Headache Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Structured Behavioral Therapy

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

Group Type: OTHER

Structured Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Propranolol

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.

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

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

Interventions

Structured Behavioral Therapy

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

Intervention Type: BEHAVIORAL

Propranolol

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 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, Kayseri, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EC/IRB Number

Identifier Type: OTHER

Identifier Source: secondary_id

KayseriUniversity

Identifier Type: -

Identifier Source: org_study_id