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NCT Number: NCT07354126

Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine

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.

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital Lahore

Lahore, Punjab Province, 54600, Pakistan

Location status: Recruiting

Location contact

Ishfaq Ahmed, FCPS

CONTACT

[email protected]

+923334957171

Ishfaq Ahmed, FCPS

PRINCIPAL_INVESTIGATOR

Muhammad Zia-ur-Rehman, FCPS

PRINCIPAL_INVESTIGATOR

Muhammad Zia-ur-Rehman, PCPS

CONTACT

[email protected]

+923334202863

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flunarizine

Drug

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.

Propranolol

Drug

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.

Primary outcomes

  1. Reduction in migraine disability

    Time frame: 3 months

    Any reduction in migraine disability score measured by PedMIDAS will be labeled as reduction (efficacy).

Study contacts

Contact information is provided by the study sponsor or research team.

Ishafaq Ahmed, FCPS

CONTACT

[email protected]

+923334957171

Muhammad Zia-ur-Rehman, FCPS

CONTACT

[email protected]

+923334202863

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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