Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine

Muhammad Aamir Latif

Status: Enrolling

Conditions: Migraine

Treatments: Drug: Propranolol; Drug: Flunarizine

Study type: Interventional

Funder types: Other

Identifiers

NCT07354126

Dr-Ishfaq-Lhr

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Flunarizine group

Experimental group

Description:

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.

Treatment:

Drug: Flunarizine

Propranolol group

Experimental group

Description:

Patients will be given propranolol beginning with 10 mg/24 hours and increasing at the rate of 10 mg/week to the maximum of 60 mg/24 hours over a 3-month treatment period.

Treatment:

Drug: Propranolol