Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine

Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine Using the PedMIDAS Measuring Tool.

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Flunarizine; Drug: Propranolol

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ishafaq Ahmed, FCPS; Phone Number: +923334957171; Email: quaidian245ishfaq@gmail.com
• Study Contact Backup: Name: Muhammad Zia-ur-Rehman, FCPS; Phone Number: +923334202863; Email: drzia81@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54600
      • Recruiting
      • The Children's Hospital Lahore
      • Contact: Ishfaq Ahmed, FCPS; Phone Number: +923334957171; Email: quaidian245ishfaq@gmail.com
      • Contact: Muhammad Zia-ur-Rehman, PCPS; Phone Number: +923334202863; Email: drzia81@gmail.com
      • Principal Investigator: Ishfaq Ahmed, FCPS
      • Principal Investigator: Muhammad Zia-ur-Rehman, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flunarizine group; 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.	Drug: Flunarizine; 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.
Experimental: Propranolol group; 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.	Drug: Propranolol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in migraine disability	Any reduction in migraine disability score measured by PedMIDAS will be labeled as reduction (efficacy).	3 months

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Ishafaq Ahmed, FCPS, The Children's Hospital Lahore; Study Director: Muhammad Zia-ur-Rehman, FCPS, The Children's Hospital Lahore

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Amines; Alcohols; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Propanols; Piperazines; Propranolol; Flunarizine
• Other Study ID Numbers: Dr-Ishfaq-Lhr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No