RESOLUTION – Preventative treatment for migraine in patients with medication overuse headaches

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
Trial Status
Recruiting
Trial Phase
Phase 4 Drug Trial
Trial contact details
Contact Person
Delphine Levy-Bencheton
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.

All research clinical trials news

2023 was an outstanding year for Mater Research with $13.7 million in grant funding received and 424 publications recorded.

29

Feb

Highlighting Mater Research’s year of achievements: 2023 Annual Report

When Monique Perry was diagnosed with aggressive triple-negative breast cancer she feared her family history was about to repeat itself.

27

Oct

Clinical trials give Queensland breast cancer patients hope

Mater researchers in Brisbane are leading a trial of a game-changing flu vaccine that has the potential to provide greater and more durable protection against the virus.

23

May

Mater launches trial of Australian-first flu vaccine

Displaying results 1-3 (of 18)
 |<  < 1 - 2 - 3 - 4 - 5 - 6  >  >|