Ongoing Clinical Trials for Medication Overuse Headache
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for medication overuse headache. This trial is testing eptinezumab, a preventive medication given through intravenous infusion, in combination with educational interventions for patients who experience both chronic migraine and medication overuse headache. The study is being conducted across multiple European countries.
Clinical trial locations
- Denmark
- France
- Germany
- Italy
- Netherlands
- Norway
- Spain
- Sweden
Study of Eptinezumab as Add-on Treatment for Prevention of Migraine in Adults with Both Migraine and Medication Overuse Headache
This trial focuses on a challenging situation that affects many people: having both chronic migraine and medication overuse headache. When people experience frequent headaches, they often take pain medications more regularly. However, this frequent use of headache medications can paradoxically lead to even more headaches, creating a difficult cycle to break.
What is the trial testing?
The study is investigating eptinezumab, also known as VYEPTI or Lu AG09221. This medication belongs to a newer class of migraine treatments called CGRP inhibitors, which work by blocking a protein involved in causing migraine headaches. Unlike traditional headache pills, eptinezumab is given through an intravenous infusion directly into a vein. The trial will examine whether this medication, combined with basic education about headaches, can help prevent migraines and address the problem of medication overuse.
Participants in this trial will also receive a Brief Education Intervention, which is not a medication but rather an educational approach. This intervention teaches patients about their condition, including information about migraine triggers, lifestyle changes that may help, and proper use of medications to prevent overuse.
Who can participate?
To be eligible for this trial, you must meet several criteria:
- Be between 18 and 75 years old
- Have been diagnosed with chronic migraine, meaning you experience headaches on 15 or more days per month
- Have experienced at least 8 migraine days per month for each of the last 3 months
- Have been living with migraines for at least 12 months, with your first migraine occurring when you were 50 years old or younger
- Currently be using medications for acute headache treatment regularly for more than 3 months
- Have been diagnosed with medication overuse headache
- Have tried at least one preventive treatment in the past 5 years that did not work adequately
- Be willing to track your headaches using an electronic diary, completing entries for at least 24 out of 28 days during the screening period
Who cannot participate?
You will not be able to join this trial if you:
- Are younger than 18 or older than 65 years
- Are pregnant or breastfeeding
- Have had a stroke or temporary stroke-like symptoms within the past 6 months
- Have other chronic pain conditions besides migraine
- Have received botulinum toxin treatments for headaches in the past 4 months
- Have a history of substance abuse or addiction within the past year
- Have serious medical conditions such as severe heart disease, uncontrolled high blood pressure, or severe kidney or liver problems
- Are currently participating in other clinical trials
- Have known allergies to the study medication or its components
- Have mental health conditions that could affect your ability to accurately report symptoms
- Have previously tried three or more preventive migraine medications without success
What happens during the trial?
The study will last for 72 weeks and involves several phases:
Step 1: Initial screening period
You will need to keep a headache diary for 28 days using an electronic device. This diary must be completed for at least 24 out of 28 days to continue in the study. During this time, researchers will monitor your current headache patterns and medication use.
Step 2: Treatment assignment
You will be randomly assigned to receive either eptinezumab or a placebo. Neither you nor your doctor will know which treatment you are receiving. The medication will be given through an intravenous infusion directly into your vein. You may receive up to 300 milligrams of the study medication during the trial.
Step 3: First 4 weeks of treatment
You will continue using the electronic diary to record your headaches and medication use. Researchers will monitor your headache frequency, pain levels, the number of days you experience migraine headaches, and your use of acute headache medications.
Step 4: Weeks 5-12 of treatment
Continued monitoring of your headache patterns through the diary will occur. The research team will assess changes in your migraine frequency, track your acute medication use, and evaluate whether you still meet the criteria for chronic migraine and medication overuse headache.
Step 5: Final assessment
At the end of the 12-week period, researchers will evaluate changes in your headache patterns, pain levels, and medication use patterns. They will make a final determination of your migraine and medication overuse status.
What is eptinezumab?
Eptinezumab is a specialized medication designed specifically for migraine prevention in adults, including those with medication overuse headache. It is a humanized monoclonal antibody, which means it is a laboratory-produced molecule that acts like a natural antibody in your body. The medication works by targeting and blocking calcitonin gene-related peptide, or CGRP, a protein involved in pain transmission and inflammation in the nervous system. By blocking this protein, eptinezumab aims to reduce both the frequency and severity of migraine attacks. This medication represents a newer generation of preventive migraine treatments and has shown effectiveness in reducing monthly migraine days and improving quality of life for patients with chronic migraine in clinical studies.
Summary
Currently, only one clinical trial is actively recruiting patients with medication overuse headache. This trial represents an important research effort to address a particularly challenging condition that affects many people who suffer from frequent migraines. The study is notable for its broad geographic reach across eight European countries, including Germany, Sweden, Spain, France, Norway, the Netherlands, Italy, and Denmark, making it accessible to a wide range of potential participants.
The trial focuses on eptinezumab, a CGRP inhibitor that represents a relatively new approach to migraine prevention. What makes this study particularly relevant is its specific focus on the dual problem of chronic migraine combined with medication overuse headache, a cycle that can be difficult to break with traditional approaches alone. By combining medication with educational interventions, the trial aims to address both the biological and behavioral aspects of this condition.
The comprehensive nature of the study, with its 72-week duration and careful monitoring through electronic diaries, reflects the complexity of treating medication overuse headache and the need for long-term assessment of treatment effectiveness. For patients struggling with this condition who meet the eligibility criteria and live in one of the participating countries, this trial offers an opportunity to access a newer treatment approach while contributing to medical knowledge that may benefit others with similar challenges in the future.
