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 Health0 个研究点目标入组 40 人开始时间: 2021年11月26日最近更新: 2022年9月5日

适应症

试验速览

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•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

•- 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

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