NCT07180043Completed
Propranolol for Pediatric Migraine: A Prospective Clinical Study
Clinical Predictors of Propranolol Responsiveness in Pediatric Migraine: A Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 18 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 178 (actual)
- First submitted
- 4 Sept 2025
- Start date
- 1 Jan 2021
- Primary completion date
- 1 Jan 2023
- Lead sponsor
- Kayseri University
- Diseases
- Migraine
- NCT number
- NCT07180043
What you commit to
- Study type: Interventional
- Participants enrolled: 178
- From 1 Jan 2021 to the primary completion date, 1 Jan 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Incomplete clinical data or loss to follow-up
Who the study is looking for
- 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
Age in the registry: 6 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kayseri University Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
Related publications
- Clinical predictors of propranolol responsiveness in pediatric migraine: a prospective observational study.J Oral Facial Pain Headache · 2026 · PMID 41914064
This page is information, not medical advice. Discuss any trial with your doctor.