ACTRN12621001616864
Recruiting
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Alfred Health
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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