NCT07354126

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Reduction in migraine disability

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

    3 months

Study Arms (2)

Flunarizine group

EXPERIMENTAL

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

Propranolol group

EXPERIMENTAL

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

Interventions

FlunarizineDRUG

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.

Flunarizine group
PropranololDRUG

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.

Propranolol group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital Lahore

Lahore, Punjab Province, 54600, Pakistan

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

FlunarizinePropranolol

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Ishafaq Ahmed, FCPS

    The Children's Hospital Lahore

    PRINCIPAL INVESTIGATOR

  • Muhammad Zia-ur-Rehman, FCPS

    The Children's Hospital Lahore

    STUDY DIRECTOR

Central Study Contacts

Ishafaq Ahmed, FCPS

CONTACT

+923334957171quaidian245ishfaq@gmail.com

Muhammad Zia-ur-Rehman, FCPS

CONTACT

+923334202863drzia81@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

September 1, 2025

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations

PA(1)