Flunarizine versus propranolol for preventing migraines in children
Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine Using the PedMIDAS Measuring Tool.
This trial will test whether flunarizine or propranolol better reduces migraine attacks in children aged 8 to 15.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 8 Years to 15 Years |
| Sex | All |
| Sponsor | RESnTEC, Institute of Research Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07354126 on ClinicalTrials.gov |
What this trial studies
This interventional comparison gives children with migraine either flunarizine or propranolol as a preventive medication and follows them for changes in attack frequency and disability. Eligible participants are 8–15 years old, meet ICHD-3 migraine criteria, experience ≥4 attacks per month, and have a PedMIDAS score ≥11. Outcomes will include change in PedMIDAS score, migraine frequency, and recording of adverse events while participants attend regular in-person follow-ups at the study site. Safety exclusions include secondary headache causes and contraindications such as cardiovascular or respiratory conditions.
Who should consider this trial
Good fit: Children aged 8–15 with migraine (with or without aura) per ICHD-3, who have at least four migraine attacks per month and a PedMIDAS score of 11 or higher, and who have no contraindications to the study drugs.
Not a fit: Children with secondary headache disorders, known hypersensitivity or contraindications to flunarizine or propranolol (including certain heart or lung conditions), those unable to attend regular follow-ups, or recent participants in other trials are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians choose the more effective and better-tolerated preventive medicine for children with frequent migraines, reducing attack frequency and disability.
How similar studies have performed: Both flunarizine and propranolol have shown preventive benefit in adult trials and in some pediatric reports, but direct head-to-head evidence in children is limited and results have been inconsistent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children of any gender * Aged 8-15 years * Diagnosed with migraine (with/without aura) per International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria * A history of ≥4 migraine attacks/month for the preceding 3 months * With a PedMIDAS score ≥11 (moderate-to-severe impact) Exclusion Criteria: * Children with secondary headache disorders (e.g., due to infections, trauma, structural brain lesions) * Known hypersensitivity or contraindications to flunarizine or propranolol * Presence of cardiovascular disorders (e.g., bradycardia, heart block, hypotension, asthma) * Non-compliance or inability to attend regular follow-ups * Participation in another clinical trial within the last 3 months
Where this trial is running
Lahore, Punjab Province
- The Children's Hospital Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Ishafaq Ahmed, FCPS — The Children's Hospital Lahore
- Study coordinator: Ishafaq Ahmed, FCPS
- Email: quaidian245ishfaq@gmail.com
- Phone: +923334957171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.