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Study on Eptinezumab for Migraine: Understanding How It Works and Finding Patient Response Markers for Migraine Sufferers

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying migraine, a common condition characterized by severe headaches that can be accompanied by other symptoms like nausea and sensitivity to light. The treatment being tested in this study is called eptinezumab, which is also known by its code name ALD403. Eptinezumab is administered as a concentrate for solution for infusion, meaning it is given through an intravenous infusion, which is a method of delivering medication directly into the bloodstream.

The purpose of the study is to explore how eptinezumab works in the body and to identify potential markers that could predict how well patients respond to the treatment. Participants in the study will receive eptinezumab at a dose of 100 mg, and the effects will be observed over a period of 12 weeks. The study will look at changes in certain biological markers and how these changes relate to the effectiveness of the treatment. Some participants may receive a higher dose of 300 mg to compare the effects between different dosages.

Throughout the study, researchers will monitor various indicators in the body, such as levels of certain proteins and brain activity related to pain processing. These observations will help determine how eptinezumab affects the body and whether it can effectively reduce migraine symptoms. The study aims to provide valuable insights into the treatment of migraines and improve understanding of how eptinezumab can benefit patients suffering from this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing your medical history and migraine condition.
You will be asked to provide information about your migraine frequency and any previous treatments you have tried.
Step 2
Consent and baseline measurements
You will be required to sign an informed consent form, indicating your understanding and agreement to participate in the study.
Baseline measurements will be taken, which may include blood tests and other assessments to establish initial health parameters.
Step 3
First infusion
You will receive your first dose of the study medication, eptinezumab, through an intravenous infusion. This involves administering the medication directly into your bloodstream via a vein.
The dosage for this infusion is 100 mg.
Step 4
Follow-up visits
Regular follow-up visits will be scheduled to monitor your response to the treatment and to conduct further assessments.
These visits will occur periodically over the course of the study, which lasts for 12 weeks initially.
Step 5
Second infusion
At the 12-week mark, you will receive a second infusion of eptinezumab. The dosage may be adjusted based on your response to the initial treatment.
This infusion will also be administered intravenously.
Step 6
Final assessments
At the end of the 12-week period, final assessments will be conducted to evaluate the effectiveness of the treatment.
These assessments may include blood tests and other evaluations to measure changes in your migraine condition.

Who can join the trial?

9 criteria

Individuals must be 18 years or older.
Participants should be right-handed.
Participants must be able to sign the informed consent on their own before joining the study.
Participants should have a history of migraine with or without aura for at least 12 months before joining the study. Aura refers to sensory disturbances some people experience before a migraine.
Participants must be eligible for treatment with eptinezumab, a medication used for migraine prevention, according to the current rules of the Italian Health System.
Participants should have a migraine frequency of at least 8 migraine days per month on average over the three months before joining the study.
Participants must have failed to respond to three or more previous preventive treatments for migraines. This means the treatments did not reduce the frequency, duration, or severity of migraines, or they had to stop the treatments due to side effects.
Participants should have a moderate or severe migraine-related disability according to the Migraine Disability Assessment (MIDAS) questionnaire. This questionnaire measures how migraines affect daily activities.
Female participants who can have children must use at least one specified method of birth control during the study. These methods include hormonal birth control, surgical procedures like tubal ligation, intrauterine devices, having a partner who has had a vasectomy, practicing true abstinence, or using barrier methods like condoms with or without spermicide.

Who cannot join the trial?

8 criteria

Patients who have any other significant health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures.
Patients who have an allergy or sensitivity to the study medication or its ingredients.
Patients who have used certain medications that might interfere with the study results.

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Ospedale San Raffaele S.r.l.
Milan, Italy

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Investigated drugs

Eptinezumab is a medication used in this clinical trial to help people who suffer from migraines. It works by targeting a specific protein in the body that is involved in causing migraine headaches. By blocking this protein, eptinezumab can help reduce the frequency and severity of migraines. In this study, researchers are looking at how eptinezumab affects both the central and peripheral parts of the nervous system, which are involved in the sensation of pain. They are also trying to find out if there are any specific signs, called biomarkers, that can predict how well a patient will respond to the treatment.

Eptinezumab

What is already known about the treatment

Eptinezumab – Eptinezumab is administered through an intravenous infusion, meaning it is given directly into the bloodstream via a vein. It is currently being studied in clinical trials for its effectiveness in treating migraines, a common and often debilitating headache disorder. The medication works by targeting a protein in the body called calcitonin gene-related peptide (CGRP), which is involved in the development of migraine headaches. By blocking the action of CGRP, eptinezumab helps to prevent migraines from occurring. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. It can be accompanied by nausea, vomiting, and sensitivity to light and sound. The progression of a migraine attack typically involves four stages: prodrome, aura, headache, and postdrome. During the prodrome phase, individuals may experience mood changes, food cravings, or neck stiffness. The aura phase can include visual disturbances or other sensory changes. The headache phase is marked by severe pain, while the postdrome phase involves fatigue and difficulty concentrating.