Migraine
Conditions
Brief summary
Flunarizine and propranolol have demonstrated efficacy in reducing migraine frequency across age groups, though evidence in pediatric populations remains limited and inconsistent. Therefore, the current study has been planned to evaluate and compare the effectiveness of flunarizine and propranolol in reducing migraine frequency in children aged 8-15 using the Pediatric Migraine Disability Assessment Scale (PedMIDAS) score.
Detailed description
Despite the clinical use of flunarizine and propranolol, direct comparisons between these two drugs in children are scarce. This study aims to bridge that gap by evaluating their relative effectiveness and safety as prophylactic treatments for pediatric migraine, addressing a critical unmet need in current research. Considering the routine use of both drugs in clinical practice, the findings would help clinicians to choose the more convenient drug between flunarizine and propranolol as preventive therapy for migraine in their local settings.
Interventions
DRUGFlunarizine
Patients will be receiving flunarizine beginning with 5 mg at bedtime and increasing it to 10 mg at bedtime after 1 month, over a 3-month treatment period.
DRUGPropranolol
Patient will be given propranolol beginning with 10 mg/24 hours and increase at the rate of 10 mg/week to the maximum of 60 mg/24 hour, over a 3-month treatment period.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in migraine disability | 3 months | Any reduction in migraine disability score measured by PedMIDAS will be labeled as reduction (efficacy). |
Countries
Pakistan
Contacts
CONTACTIshafaq Ahmed, FCPS
CONTACTMuhammad Zia-ur-Rehman, FCPS
PRINCIPAL_INVESTIGATORIshafaq Ahmed, FCPS
The Children's Hospital Lahore
STUDY_DIRECTORMuhammad Zia-ur-Rehman, FCPS
The Children's Hospital Lahore
Outcome results
None listed