Study on Migraine: Effects of Fremanezumab on Brain Chemistry in Patients with and without Aura

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What is this study about?

This clinical trial is focused on studying migraine, a common type of headache that can cause severe pain and other symptoms. The study is investigating a treatment using a medication called Fremanezumab, which is also known by its code name PF-04427429. This medication is given as a solution for injection and is designed to target a specific protein in the body that is involved in causing migraines. The purpose of the study is to explore whether this treatment can lead to changes in certain chemicals in the brain, particularly in areas called the occipital cortex and the thalamus, which are involved in processing visual information and sensory signals.

Participants in the study will receive Fremanezumab injections once a month. The study will compare the effects of the treatment on patients with migraines, both with and without aura, which is a visual or sensory disturbance that can occur before a migraine. Researchers will use a technique called MR-Spectroscopy to measure changes in brain chemicals before and after the treatment period. This technique allows scientists to look at the levels of different substances in the brain without needing to perform surgery.

Throughout the study, changes in migraine frequency and intensity will be monitored using questionnaires. The study aims to understand if there is a link between the changes in brain chemicals and the symptoms experienced by patients. By the end of the study, researchers hope to gain insights into how Fremanezumab affects the brain and whether it can be an effective treatment for reducing the impact of migraines.

1 joining the study

Upon joining the study, written informed consent is required. This ensures understanding and agreement to participate in the trial.

Eligibility is confirmed based on age (18-65 years), a history of migraine with or without aura for more than 12 months, and a migraine frequency of 4 to 15 days per month.

2 baseline assessment

An initial assessment is conducted to establish baseline measurements. This includes an MR spectroscopy to measure neurotransmitter levels in the brain.

Participants must not have received CGRP monoclonal antibodies for migraine prevention before.

3 treatment phase

The treatment involves receiving a fremanezumab injection, known as AJOVY 225 mg, administered subcutaneously once a month.

This phase lasts for 12 weeks, during which the medication is expected to influence neurochemical changes in the brain.

4 follow-up assessments

Follow-up visits include MR spectroscopy to assess changes in neurotransmitter levels in the occipital cortex and thalamus.

The frequency and intensity of migraines are evaluated using questionnaires such as MIDAS and HIT-6.

5 completion of the study

The study concludes with a final assessment to compare neurochemical and metabolic changes in participants with and without aura.

The correlation between these changes and clinical symptoms like migraine frequency, intensity, or duration is analyzed.

Who Can Join the Study?

You must provide written informed consent before any assessments are done. This means you agree to participate after understanding the study details.
You need to be an adult between 18 and 65 years old when you start the screening process.
You should have a documented history of migraine with or without aura for more than 12 months before the screening. This is based on a specific classification of headache disorders.
Your migraine frequency should be between 4 and 15 migraine days per month over the last 3 months before screening. This is based on your past reports.
You must not have received a CGRP monoclonal antibody for preventing migraines in the past. CGRP is a type of treatment for migraines.
You should be able to tell the difference between a migraine and other types of headaches.
You must not have any contraindications for MRI. This means there should be no medical reasons that prevent you from having an MRI scan.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to similar medications are excluded.
People with other significant health conditions that might interfere with the study are not eligible.
Participants who are currently using other treatments for migraines that cannot be stopped are excluded.
Individuals with a history of drug or alcohol abuse in the past year cannot join the study.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Anyone with a known sensitivity to the study medication or its ingredients is excluded.
Individuals with certain mental health conditions that might affect their ability to participate are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.12.2021

Trial locations

Investigated drugs:

Fremanezumab

Fremanezumab is a medication used in this clinical trial to treat patients with migraines. It is a type of CGRP antibody, which means it works by blocking a protein in the body that is involved in causing migraine headaches. The trial aims to see if this treatment can lead to changes in brain chemistry, specifically in areas of the brain like the occipital cortex and the thalamus, which are associated with migraines.

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. These headaches can last from a few hours to several days and may occur with or without an aura, which includes visual disturbances or other sensory changes. The condition progresses through four stages: prodrome, aura, headache, and postdrome, though not everyone experiences all stages. Migraine attacks can vary in frequency and intensity, affecting daily activities and quality of life. The exact cause of migraines is not fully understood, but they are believed to involve changes in brain chemicals and nerve pathways. Triggers can include stress, certain foods, hormonal changes, and environmental factors.

Trial ID:

2024-517079-19-00

Protocol code:

MRSI

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Migraine: Effects of Fremanezumab on Brain Chemistry in Patients with and without Aura

What is this study about?

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