Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flunarizine, Propranolol.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 8 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine Using the PedMIDAS Measuring Tool.
Overview
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
- 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. - 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.
Primary outcome measures
- Reduction in migraine disability [Time frame: 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- The Children's Hospital Lahore — Lahore
Identifiers
NCT: NCT07354126 · Dr-Ishfaq-Lhr