Study on Eptinezumab for Preventing Chronic Migraine in Adults

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Kiepury Clinic Malgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno-Położnicza	Sosnowiec	Poland

Other Sites

Site Name	City	Country
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Silmedic Sp. z o.o.	Katowice	Poland
Solumed Sp. z o.o. sp.k.	Poznan	Poland
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Centrum Medyczne Kuba-Med 2 Sp. z o.o.	Zamosc	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Pratia S.A.	Skorzewo	Poland
Centrum Leczenia MIGRE	Wroclaw	Poland
Savityk scsypm Nxjjrqtexdnq alyqtwoooh	Presov	Slovakia
Meona Bwbog Drqubhtp nqhqbdopzkvw aqgpjfwysa spdlwh	Banska Bystrica	Slovakia
Ig Mxrub sfkkgk	Bardejov	Slovakia
Pbkwzcl Mskdiq Shb z Ovqz Eig Psvusuokp	Poniatowa	Poland
Fmesuwkrj Pynw Ll Ifknfpgevyvlz Blrphsowa Dqx Hwmzessh Ugukzhzejujag Lm Pfp	Madrid	Spain
Hoqfwvom Vwxc dgrcqprm	Barcelona	Spain
Ibvdukfb Zeasqjx Dj Bvnjtjwvqgpissvjo	Oświęcim	Poland
Kxpkghloc scggfv	Dubnica nad Váhom	Slovakia

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	29.05.2021
Slovakia	Not recruiting	29.05.2021
Spain	Not recruiting	29.05.2021

Trial locations

Investigated drugs:

Eptinezumab

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.

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.

Trial ID:

2023-510183-12-00

Protocol code:

19140A

NCT ID:

NCT04921384

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Eptinezumab for Preventing Chronic Migraine in Adults

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