Comorbidity-Based Propranolol Use in Pediatric Migraine

NCT07103031 | Completed

• 2 other identifiers: KayseriUniversity12EC/IRB Number- 2021/12-14
• Study Type: observational
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Migraine; Migraine Disorders, Brain; Vitamin D Deficiency

Keywords

Propranolol; Pediatric Migraine; Migraine Prophylaxis; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score

  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.

  Baseline to 3 months after treatment

Secondary Outcomes (1)

• Visual Analog Scale (VAS) Pain Scores

  Baseline to 3 months after treatment

Study Arms (2)

Group 1

Behavioral therapy group

Behavioral: Behavioral therapy

Group 2

Propranolol group

Drug: Propranolol

Interventions

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.

Also known as: Cognitive-Behavioral Therapy

Group 1

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.

Also known as: β-blocker

Group 2

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of pediatric patients aged \[2-19\] who were diagnosed with primary headache disorders, specifically migraine, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). Participants were evaluated and followed at the pediatric neurology outpatient clinic of a tertiary care hospital between January 2021 and December 2023. Patients with confirmed comorbid conditions (e.g., anxiety, benign paroxysmal vertigo, essential tremor) and/or vitamin deficiencies were included to assess the impact of these factors on treatment response. Those with secondary headache, neurological disorders, or incomplete records were excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri University: lead

Study Sites (1)

Kayseri University

Kayseri, 38130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Vitamin D Deficiency

Interventions

Behavior Therapy; Cognitive Behavioral Therapy; Propranolol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 5, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)