Study on the Safety and Effectiveness of MEDI0618 for Reducing Migraine Days in Adults with Episodic Migraine

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What is this study about?

This clinical trial is focused on studying episodic migraine, a type of headache that occurs with varying frequency and can be quite painful. The study is testing a new treatment called MEDI0618, which is given as a solution for injection under the skin. The purpose of the study is to see if MEDI0618 can help reduce the number of migraine headache days in adults who experience these types of headaches.

Participants in the study will receive either the MEDI0618 treatment or a placebo, which is a substance with no active medication. The study will last for several weeks, during which participants will receive multiple doses of the treatment. The researchers will monitor the participants to see how the treatment affects the frequency of their migraine headaches and to ensure the safety of the treatment.

The study aims to provide valuable information about the effectiveness and safety of MEDI0618 in preventing migraine headaches. By participating, individuals will contribute to research that could lead to better treatment options for people suffering from episodic migraines in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and history of migraine headaches.

Participants must have experienced a certain number of migraine headache days (MHDs) in the months prior to the study.

2 baseline data collection

Participants record migraine headache data for four consecutive weeks before the first day of treatment.

This data helps establish a baseline for comparison during the study.

3 randomization and treatment initiation

Participants are randomly assigned to receive either the medication MEDI0618 or a placebo.

The treatment is administered as a subcutaneous injection, which means it is injected under the skin.

4 treatment period

The treatment period lasts for 12 weeks.

Participants receive repeat doses of the assigned treatment throughout this period.

5 monitoring and data collection

Participants continue to record the number of migraine headache days during the treatment period.

This data is used to assess the effectiveness of the treatment in reducing migraine headache days.

6 end of treatment evaluation

At the end of the treatment period, the change in the number of migraine headache days from the baseline is evaluated.

This evaluation helps determine the efficacy of MEDI0618 compared to the placebo.

Who Can Join the Study?

Age between 18 and 70 years old.
Weight of at least 40 kg and a Body Mass Index (BMI) of at least 18.0 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.
History of migraine headaches, with or without aura, starting at or before 50 years of age and having them for at least 12 months before the study begins. An aura is a visual or sensory disturbance that can occur before a migraine.
At least 12 migraine headache days (MHDs) over the last 3 months before the study begins.
During the 4 weeks before the study starts, participants must have between 4 and 14 MHDs per month. On at least 4 days, they must have one of the following: migraine without aura, migraine with an aura followed by a headache within 60 minutes, probable migraine, or recurrent attacks that respond to migraine-specific medication.
Participants who meet the criteria for Medication Overuse Headache (MOH) are eligible. MOH is a condition where frequent use of headache medication can lead to more headaches.
History of unsuccessful treatment with at least 3 different types of small molecule migraine preventive treatments. Participants who have not yet received a therapy called aCGRP can join, but those who have tried and failed at least one aCGRP therapy can also join. aCGRP therapies are treatments that target a specific protein involved in migraines.
Participants must be able to tell the difference between migraine headaches and tension-type headaches. Tension-type headaches are usually less severe and feel like a tight band around the head.
Female participants must not be pregnant, not planning to become pregnant during the study, not breastfeeding, or unable to have children. Females of childbearing potential (FOCBP) who are sexually active with a non-sterilized male partner must use effective contraception during the study. FOCBP must agree to follow the study’s guidelines for the safe use of the study medication, MEDI0618.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any of the ingredients in the study medication.
Individuals currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse within the past year.
Women who are pregnant or breastfeeding.
Individuals with other significant health conditions that might interfere with the study.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Individuals who are unable to comply with the study procedures or follow-up visits.
Patients who have used certain medications that might interfere with the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Pharmakologisches Studienzentrum Chemnitz GmbH	Chemnitz	Germany
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Praglandia s.r.o.	Prague	Czechia
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Hospital Del Mar	Barcelona	Spain
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Centrum Medyczne Hcp Sp. z o.o.	Poznan	Poland
Solumed Sp. z o.o. sp.k.	Poznan	Poland
Specjalistyczne Gabinety Sp. z o.o.	Cracow	Poland
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
Clintrial s.r.o.	Prague	Czechia
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Irccs San Raffaele Roma S.r.l.	Rome	Italy
Pratia S.A.	Skorzewo	Poland
Vestra Clinics s.r.o.	Rychnov Nad Kneznou	Czechia
Rigshospitalet	Copenhagen	Denmark
Forbeli s.r.o.	Prague	Czechia
Kopfschmerzzentrum Frankfurt	Frankfurt	Germany
Centrum Medyczne HOPE Clinic Sebastian Szklener	Lublin	Poland
Afnw Czegkzcg sopbnh	Prague	Czechia
Uixlqisfeaugipghjdlcb Etcsp Akc	Essen	Germany
Laofr Ugfajvskkodt Mtevxlh Cxujrai (jypgd	Leiden	The Netherlands
Hsomhcvn Uorszovfnilaj Dd Bywsykj	Badajoz	Spain
Btheakpzsjhieuewv sgqnbg	Kladno	Czechia
Dttt Mtsopnj sklwjb	Prague	Czechia
Iavzxixg Nepdkzfwmxkzykzqul Pspr (gfvlz	Prague	Czechia
Koqllfgp dgm Ucdsvbyhlabb Mxiwpnyd Apc	Munich	Germany
Fjggrtbjg Puul Le Ickxjsiluwkow Byeaxwyas Doo Hepofgnk Uncinzwdfoinj Ll Pzc	Madrid	Spain
Hgyobbyx Vwqw dtqyczql	Barcelona	Spain
Socudlybi Kvqj	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.11.2024
Denmark	Recruiting	01.11.2024
Germany	Recruiting	01.11.2024
Hungary	Recruiting	01.11.2024
Italy	Recruiting	01.11.2024
Poland	Recruiting	01.11.2024
Spain	Recruiting	01.11.2024
The Netherlands	Not yet recruiting	01.11.2024

Trial locations

Investigated drugs:

Medi0618

MEDI0618 is an investigational medication being studied for its potential to reduce the number of migraine headache days in adults who experience episodic migraines. It is administered through an injection under the skin. The study aims to determine how effective and safe this medication is when given repeatedly to prevent migraines.

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last from a few hours to several days and may occur with varying frequency. Some individuals experience warning symptoms known as aura, which can include visual disturbances or tingling sensations. The exact cause of migraines is not fully understood, but they are believed to involve genetic and environmental factors. Triggers can include stress, certain foods, hormonal changes, and sensory stimuli.

Trial ID:

2024-512904-21-00

Protocol code:

D7060C00003(M26-031)

NCT ID:

NCT06602479

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of MEDI0618 for Reducing Migraine Days in Adults with Episodic Migraine

What is this study about?

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