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
Alfred Health
40 participants
Apr 27, 2022
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
Inclusion Criteria7
- Aged 18 to 65 inclusive at time of presentation to ED
- At least a 1-year history of migraine with or without aura as per the ICHD-3 criteria
- Age of participant at the time of migraine onset <50 years old
- An acute migraine attack that has persisted for greater than or equal to 72 hours as per the ICHD-3 criteria for status migrainosus
- Ongoing symptoms despite, or contraindication to, triptan and chlorpromazine therapy
- In the opinion of the investigator and treating doctor, adequate investigation and consideration has been given for secondary causes of headache prior to enrolment.
- Written informed consent obtained from the participant prior to any study-related procedures
Exclusion Criteria19
- History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
- Current concomitant diagnosis of a secondary type of headache
- Chronic headache with continuous pain lasting more than three weeks
- Headache, which in the opinion of the investigator or delegate requires further investigation for secondary causes of headache
- Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal or neurologic disease
- Received an anti-CGRP product within 6 months
- History of known hepatic disease with potential for hepatic function impairment
- History of myocardial infarction, stroke, transient ischaemic attack, unstable angina or revascularisation procedure
- Cardiac arrythmia
- Newly diagnosed or uncontrolled hypertension
- Currently received treatment for another investigational drug or within 5 half-lives since ending treatment of another investigational drug.
- Clinically significant confounding pain disorder
- Uncontrolled or untreated major psychiatric condition
- BMI >39kg/m2
- Women who are pregnant, breastfeeding or planning to become pregnant during the study
- Previous ADR to lignocaine or other local anaesthetics
- History of malignancy (other than non-melanoma skin cancer, fully treated by excision)
- Previously received intravenous lignocaine for status migrainosus
- Need for contraindicated pro-arrhythmic or QT prolonging medication contraindicating lignocaine infusion
Interested in this trial?
Get notified about updates and connect with the research team.
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 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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12621001616864