Authorised Therapeutic exploratory (Phase II) Nervous System Diseases

Exploration of the pathophysiology of cluster headache (AVF) in PET-MRI using [18F]F13640

EU CTIS ID: 2024-513873-36-00

What this study is testing

In a group of patients with episodic AVF, assessment of the difference: - fixing the [18F]F13640 (for PET data), - perfusion, brain activity and functional connectivity (for MRI data) between the active and inactive period of the disease.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients with episodic AVF: • Male;
  • Patients with episodic AVF: • Age between ≥ 18 and ≤ 60 years;
  • Patients atteints d’AVF épisodique : • De poids compris entre 50 et 110 kg ;
  • Patients with episodic AVF: • Algic crisis (or “crisis”) occurring between 11:00 a.m. and 9:00 p.m.
  • Patients with episodic AVF: • No psychiatric or neurological history other than AVF;
  • Patients with episodic AVF: • No history of head trauma with loss of consciousness lasting more than 30 minutes;

You likely can't join if

  • Patients with present or past dependence on alcohol or any other addictive substance according to DSM-IV-TR criteria, with the exception of nicotine, caffeine and cannabis
  • • Patients already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation
  • Patients with a contraindication to MRI examinations: people suffering from claustrophobia and/or people using a pacemaker or an insulin pump, people wearing a metal prosthesis or an intracerebral clip as well as claustrophobic subjects, neurosensory stimulator or defibrillator implantable, cochlear implants, ferromagnetic ocular or cerebral foreign bodies close to nervous structures, agitation of the subject (uncooperative or agitated subjects), neurosurgical ventriculoperitoneal diversion valves, dental appliance;
  • •Patients with a contraindication to [18F]F13640 PET examinations: hypersensitivity to the active substance or to one of the excipients (sodium chloride);
  • Patients with a contraindication to sumatriptan: hypersensitivity to sumatriptan or to one of the excipients, history of myocardial infarction or ischemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease, cardiac disease ishcemic, history of stroke or TIA, severe hepatic impairment, moderate or severe hypertension and in patients with mild uncontrolled hypertension, ergotamine or ergotamine derivatives (including methysergide), another triptan/receptor agonist 5-hydroxytriptamine1 (5-HT1), combination of sumatriptan with monoamine oxidase inhibitors or within two weeks after stopping treatment with monoamine oxidase inhibitors;
  • Patients presenting an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc.) judged by the investigator;
See the full eligibility criteria
Who can join
  • Patients with episodic AVF: • Male;
  • Patients with episodic AVF: • Age between ≥ 18 and ≤ 60 years;
  • Patients atteints d’AVF épisodique : • De poids compris entre 50 et 110 kg ;
  • Patients with episodic AVF: • Algic crisis (or “crisis”) occurring between 11:00 a.m. and 9:00 p.m.
  • Patients with episodic AVF: • No psychiatric or neurological history other than AVF;
  • Patients with episodic AVF: • No history of head trauma with loss of consciousness lasting more than 30 minutes;
  • Patients with episodic AVF: • Affiliate to a social security or similar system
  • Patients with episodic AVF: • Not subject to a legal protection measure
  • Patients with episodic AVF: • Having given free and informed consent to participate in the study in writing
What rules you out
  • Patients with present or past dependence on alcohol or any other addictive substance according to DSM-IV-TR criteria, with the exception of nicotine, caffeine and cannabis
  • • Patients already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation
  • Patients with a contraindication to MRI examinations: people suffering from claustrophobia and/or people using a pacemaker or an insulin pump, people wearing a metal prosthesis or an intracerebral clip as well as claustrophobic subjects, neurosensory stimulator or defibrillator implantable, cochlear implants, ferromagnetic ocular or cerebral foreign bodies close to nervous structures, agitation of the subject (uncooperative or agitated subjects), neurosurgical ventriculoperitoneal diversion valves, dental appliance;
  • •Patients with a contraindication to [18F]F13640 PET examinations: hypersensitivity to the active substance or to one of the excipients (sodium chloride);
  • Patients with a contraindication to sumatriptan: hypersensitivity to sumatriptan or to one of the excipients, history of myocardial infarction or ischemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease, cardiac disease ishcemic, history of stroke or TIA, severe hepatic impairment, moderate or severe hypertension and in patients with mild uncontrolled hypertension, ergotamine or ergotamine derivatives (including methysergide), another triptan/receptor agonist 5-hydroxytriptamine1 (5-HT1), combination of sumatriptan with monoamine oxidase inhibitors or within two weeks after stopping treatment with monoamine oxidase inhibitors;
  • Patients presenting an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc.) judged by the investigator;
  • • Patients who have exceeded the annual amount of compensation authorized for participation in research protocols

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.