Medication overuse headache in migraine
This is a Phase IV study, evaluating the efficacy of the approved migraine drug eptinezumab, combined with a brief behavioural intervention, for prevention of migraine and treatment of medication overuse headache in patients with a dual diagnosis of migraine and medication overuse headache.
At the start of the study, participants will be instructed to stop taking acute headache medications during a semi-structured educational conversation. Participants will then be randomly assigned to receive eptinezumab or placebo by intravenous infusion for a 12 week period. After that, all participants will receive eptinezumab for another 12 weeks. Efficacy of the study intervention will be measured using headache diaries and health questionnaires completed on a mobile electronic device.
- Category
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Trial status
Active, not recruiting
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Trial phase
Phase 4 Drug TrialTrials of approved medications to provide “real world evidence” of efficacy and safety in clinical practice.
- Registry listing
Trial contact details
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Contact person
Stevie Anderson
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Phone
07 3163 1423
What you need to know
Who can take part?
- Patients 18 to 75 years old with a diagnosis of Chronic Migraine and Medication Overuse Headache
- Patients who have had migraine for at least 12 months
- Patients who have 8 or more migraine days per month
- Patients who have failed treatment with at least one migraine preventing medication in the last 5 years
What is involved for you?
- Brief educational intervention with instruction to discontinue taking acute headache medications
- One dose of eptinezumab or placebo by intravenous infusion
- One dose of eptinezumab by intravenous infusion
- Physical and neurological exam to assess eligibility
- Blood sampling to assess eligibility
- Blood pregnancy test at screening, urine pregnancy tests thereafter
- Vital sign measurements including temperature
- Electrocardiogram
- Keeping an electronic headache diary
- Keeping an electronic medication diary
- Completing questionnaires on headache symptoms, health and wellbeing on an electronic device
- Answering questions about other medications and substance use
Trial dates
This trial is accepting participants until 30 May 2024.
