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

Phase 4

Recruiting

• Conditions: Migraine; Neurological - Other neurological disorders

• Registration Number: ACTRN12621001616864
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-26
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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 Criteria

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from treatment initiation to discharge. Information collected by daily contact with participant during admission and confirmation from discharge confirmation in medical records. [At time of acute hospital discharge];Visual Analogue Scale (VAS) of pain associated with migraine[Day 1, Day 2, Day 3, Day 4 and Day 5 of admission ];Use of rescue medications during admission collected via participant medical records[At time of acute hospital discharge]