Not recruiting

Study on Eptinezumab for Preventing Chronic Migraine in Adults

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 the effectiveness and safety of a medication called eptinezumab for the prevention of chronic migraine in adults. Chronic migraine is a condition characterized by frequent and severe headache episodes that can significantly impact daily life. The medication being tested, eptinezumab, is administered as a concentrate for solution for infusion, which means it is given through a vein in the arm.

The purpose of this study is to evaluate how well eptinezumab can prevent migraines in people who experience them frequently. Participants in the study will be randomly assigned to receive either eptinezumab or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased and reliable.

Throughout the study, participants will receive regular infusions and will be monitored for changes in the number of migraine days they experience each month. The study will last for several months, allowing researchers to gather enough information to determine the effectiveness of eptinezumab in reducing the frequency of migraines. Participants will also be observed for any side effects or safety concerns related to the treatment. The ultimate goal is to find a reliable preventive treatment for those suffering from chronic migraine.

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 visit
Upon joining the study, the participant attends an initial visit. During this visit, the participant's eligibility is confirmed based on specific criteria, such as a diagnosis of chronic migraine and a history of migraine onset at least 12 months prior to this visit.
The participant must have experienced at least 8 migraine days per month for each of the past 3 months. Additionally, the participant should be between 18 and 75 years old.
Step 2
Screening period
During the screening period, the participant uses an electronic diary (eDiary) to record migraine occurrences. This period helps to confirm the frequency of migraines and headaches.
The participant must demonstrate compliance by entering data for at least 24 out of 28 days following the initial visit.
Step 3
Randomization and treatment
After the screening period, the participant is randomly assigned to receive either the study medication, eptinezumab, or a placebo. This is a double-blind study, meaning neither the participant nor the researchers know which treatment is being administered.
The medication, VYEPTI 100 mg, is administered as an intravenous infusion. The frequency and duration of administration are determined by the study protocol.
Step 4
Treatment period
The treatment period lasts for 12 weeks. During this time, the participant continues to use the eDiary to record migraine days and any other relevant information.
The primary goal is to evaluate the change in the number of monthly migraine days from the baseline.
Step 5
Evaluation
Throughout the study, the participant's response to the treatment is evaluated. Key measures include a reduction in monthly migraine days by at least 50% and 75% at various time points.
The participant's migraine rate on the day after dosing is also assessed.
Step 6
End of study
The study is estimated to conclude by July 31, 2025. At the end of the study, the participant's overall response to the treatment is reviewed, and any necessary follow-up actions are determined.

Who can join the trial?

6 criteria

The participant must have a diagnosis of chronic migraine as defined by specific guidelines, confirmed during a screening visit, with a history of migraine starting at least 12 months before the screening.
The participant must have been diagnosed with migraine before the age of 50.
The participant must have experienced at least 8 migraine days per month for each of the 3 months before the screening visit.
During the screening period, the participant must have migraines on at least 8 days and headaches on 15 to 26 days, as recorded in an electronic diary (eDiary).
The participant must have used the Headache eDiary to enter data for at least 24 out of the 28 days following the screening visit.
The participant must be between 18 (20 for Taiwan) and 75 years old at the time of the screening visit.

Who cannot join the trial?

5 criteria

Participants who do not have chronic migraine cannot join the study. Chronic migraine means having headaches on 15 or more days each month, with at least 8 of those days being migraines.
Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
People who are not part of the specified clinical trial groups are excluded. This means the study is looking for specific types of participants.
Participants who are not willing to follow the study procedures or who cannot comply with the study requirements will be excluded.
Individuals who are part of a vulnerable population, which means they might need special protection or care, may not be eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Lleida, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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Investigated drugs

Eptinezumab is a medication being studied for its ability to prevent migraines. It is designed to help reduce the frequency and severity of migraine attacks in people who experience them regularly. This medication works by targeting a specific protein in the body that is involved in the development of migraines, potentially providing relief for those suffering from chronic migraine conditions.

Eptinezumab

What is already known about the treatment

Eptinezumab – Eptinezumab is administered through an intravenous infusion, typically given every three months. It is currently being studied in clinical trials for its effectiveness in preventing chronic migraines. The medication works by targeting and blocking the activity of a protein called calcitonin gene-related peptide (CGRP), which is involved in the development of migraine headaches. Eptinezumab is classified as a monoclonal antibody, specifically designed to prevent migraines by interfering with the CGRP pathway.

Investigated diseases

Chronic Migraine – Chronic migraine is a neurological condition characterized by experiencing headaches on 15 or more days per month, with at least 8 of those days involving migraine features. These features can include throbbing pain, sensitivity to light or sound, nausea, and visual disturbances. The condition often begins with episodic migraines that increase in frequency over time. Factors such as stress, hormonal changes, and certain foods can trigger or worsen the symptoms. Chronic migraine can significantly impact daily activities and quality of life. The progression of the condition varies among individuals, with some experiencing periods of improvement and others facing persistent symptoms.