RecruitingPhase 4ACTRN12621001616864

An evaluation of the efficacy of eptinezumab in the inpatient management of status migrainosus in comparison to intravenous lignocaine in patients who have failed other therapies


Sponsor

Alfred Health

Enrollment

40 participants

Start Date

Apr 27, 2022

Study Type

Interventional

Conditions

Summary

This study is a randomised, double-blinded parallel group controlled study to evaluate the safety and efficacy of eptinezumab against lignocaine in the inpatient treatment of status migrainosus. Subjects who fulfil the International Classification of Headache Disorders, third edition criteria of migraine and status migrainosus and who have failed or are inappropriate to receive triptan and chlorpromazine therapy will be enrolled into this trial. Upon randomisation, forty subjects will be allocated in a 1:1 ratio to receive either eptinezumab 300mg or placebo infusion, and admitted to hospital to receive intravenous lignocaine as standard medical therapy (if they received a placebo infusion on randomisation), or a placebo infusion for up to five days, or until their migraine is successfully treated.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Status migrainosus is a severe, debilitating migraine that lasts for more than 72 hours and doesn't respond to standard treatments like triptans. It often requires hospitalisation. Currently, one of the main hospital treatments is a continuous intravenous infusion of lignocaine (a local anaesthetic), which can help break the migraine cycle but comes with its own risks and requires close monitoring. This trial is testing whether eptinezumab — a newer migraine-specific medication that works by blocking a protein called CGRP — could be a better or complementary option for these very difficult-to-treat migraines. Participants are randomly assigned to receive either eptinezumab or a placebo infusion upon hospital admission. All participants also receive standard hospital care. The study is double-blinded, meaning neither patients nor treating staff know who received which treatment, ensuring reliable results. You may be eligible if you are between 18 and 65, have had migraines for at least a year, and are currently experiencing a migraine lasting more than 72 hours that hasn't responded to triptan and chlorpromazine therapy. Several heart, liver, and neurological conditions, as well as pregnancy, may exclude you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A randomised, double-blinded parallel group controlled study to evaluate the safety and efficacy of eptinezumab against lignocaine in the inpatient treatment of status migrainosus. Participants ran

A randomised, double-blinded parallel group controlled study to evaluate the safety and efficacy of eptinezumab against lignocaine in the inpatient treatment of status migrainosus. Participants randomised to the Eptinezumab arm will receive 300mg via intravenous infusion over 30 minutes followed by placebo infusion (saline) for up to five days or until the migraine is aborted.


Locations(1)

The Alfred - Melbourne

VIC, Australia

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ACTRN12621001616864


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