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Study on Cluster Headache Using Befiradol (18F) for Patients with Episodic Symptoms

Verified siteInvestigationalNo 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 understanding the condition known as Cluster Headache, a type of severe headache that affects the nervous system. The study will use a special treatment called Befiradol (18F), which is an injectable substance also known by its code name [18F]-F13640. This treatment will be used in combination with advanced imaging techniques, specifically PET-MRI, to explore how the brain functions during different phases of the headache.

The purpose of the study is to assess the differences in brain activity and blood flow between the active and inactive periods of cluster headaches. Participants will undergo imaging sessions where the Befiradol (18F) will help highlight areas of the brain that are active during these periods. The study aims to provide insights into how the brain's activity changes before, during, and after a headache attack.

Throughout the study, participants will receive injections of Befiradol (18F) and undergo PET-MRI scans. These scans will help researchers compare brain activity and blood flow during different phases of the headache. The study will not only look at the immediate effects but also how these changes correlate with the overall pattern of the headaches. This research hopes to contribute to a better understanding of cluster headaches and potentially lead to improved treatments in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, weight, and medical history related to episodic cluster headaches, also known as AVF.

    Eligibility criteria include being male, aged between 20 and 45 years, and having no psychiatric or neurological history other than AVF.

  2. Step 2

    Preparation for imaging

    Preparation for imaging involves understanding the procedure and providing informed consent. The imaging will use PET-MRI technology to explore brain activity.

    The patient will be informed about the use of the substance befiradol (18f), which is administered via injection.

  3. Step 3

    Imaging sessions

    The patient undergoes imaging sessions during both active and inactive periods of the disease. These sessions aim to assess brain activity and connectivity.

    The imaging process involves the administration of befiradol (18f) to help visualize brain function and blood flow.

  4. Step 4

    Data collection

    Data is collected on brain activity, blood flow, and functional connectivity. This includes comparing different periods of the disease, such as before, during, and after a headache attack.

    The primary goal is to compare density maps of functional receptors and regional cerebral blood flow.

  5. Step 5

    Follow-up and analysis

    After the imaging sessions, follow-up assessments are conducted to monitor any changes in the patient's condition.

    The collected data is analyzed to understand the pathophysiology of cluster headaches and to identify potential correlations in brain activity.

Who can join the trial?

9 criteria

  • Must be a male patient.
  • Age should be between 20 and 45 years old.
  • Weight must be between 50 and 110 kg.
  • Experience algic crisis (pain episodes) between 11:00 a.m. and 9:00 p.m.
  • No history of psychiatric or neurological conditions other than AVF.
  • No history of head trauma with loss of consciousness lasting more than 30 minutes.
  • Must be affiliated with a social security or similar system.
  • Not under any legal protection measures.
  • Must have given free and informed consent to participate in the study in writing.

Who cannot join the trial?

3 criteria

  • Patients with any other **nervous system diseases** besides the one being studied cannot participate. The nervous system includes the brain, spinal cord, and nerves.
  • Only **male** patients are allowed to participate, so female patients are excluded.
  • Patients who are considered part of a **vulnerable population** are not eligible. This means people who might need extra protection or care, like those with certain disabilities or conditions.
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Investigated drugs

[18F]F13640 is a radiotracer used in PET-MRI scans to help visualize and study brain activity. In this clinical trial, it is used to assess differences in brain function and connectivity in patients with episodic cluster headaches during active and inactive periods of the disease.

What is already known about the treatment

[18F]F13640 – This medication is administered through an intravenous injection, primarily used in clinical trials involving PET-MRI imaging. It is currently being studied to understand its role in nervous system diseases, particularly in the context of cluster headaches. The main therapeutic indication is to assess brain activity and connectivity during different phases of the disease. At the molecular level, [18F]F13640 acts as a radiotracer, helping to visualize and measure brain function. It falls under the pharmacological classification of radiopharmaceuticals used in diagnostic imaging.

Investigated diseases

Nervous System Diseases – These are a group of disorders that affect the brain, spinal cord, and nerves throughout the body. They can disrupt the way the nervous system functions, leading to symptoms such as pain, muscle weakness, coordination problems, and changes in sensation. The progression of these diseases can vary widely; some may develop slowly over time, while others can appear suddenly. They can affect a person's ability to move, speak, or think clearly. The impact on daily life can be significant, depending on the specific disease and its severity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513873-36-00Estimated enrolment12 patientsSponsorHospices Civils De Lyon

sourced from the EU Clinical Trials Register and site verification

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