BEFIRADOL (18F) for Cluster headache | Episodic cluster headache

Inclusion criteria

• {"criterion_text":"- Patients with episodic AVF: • Male;"}
• {"criterion_text":"- Patients with episodic AVF: • Age between ≥ 18 and ≤ 60 years;"}
• {"criterion_text":"- Patients atteints d’AVF épisodique : •\t\tDe poids compris entre 50 et 110 kg ;"}
• {"criterion_text":"- Patients with episodic AVF: • Algic crisis (or “crisis”) occurring between 11:00 a.m. and 9:00 p.m."}
• {"criterion_text":"- Patients with episodic AVF: • No psychiatric or neurological history other than AVF;"}
• {"criterion_text":"- Patients with episodic AVF: • No history of head trauma with loss of consciousness lasting more than 30 minutes;"}
• {"criterion_text":"- Patients with episodic AVF: • Affiliate to a social security or similar system"}
• {"criterion_text":"- Patients with episodic AVF: • Not subject to a legal protection measure"}
• {"criterion_text":"- Patients with episodic AVF: • Having given free and informed consent to participate in the study in writing"}

Exclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- • Patients already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation"}
• {"criterion_text":"- •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;"}
• {"criterion_text":"- •Patients with a contraindication to [18F]F13640 PET examinations: hypersensitivity to the active substance or to one of the excipients (sodium chloride);"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Patients presenting an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc.) judged by the investigator;"}
• {"criterion_text":"- • Patients who have exceeded the annual amount of compensation authorized for participation in research protocols"}

Primary endpoints

• {"endpoint_text":"- Comparison of the different density maps of the functional receptors in the 2 periods Comparison of different regional cerebral blood flow maps in the 2 periods Correlations of BOLD fluctuations between distant regions: functional connectivity of patients in the 2 periods","definition_or_measurement_approach":"Measured using PET uptake of [18F]F13640 (fixation for PET data) and MRI measures of perfusion, brain activity and BOLD-based functional connectivity; comparisons between active (crisis) and inactive periods."}

Secondary endpoints

• {"endpoint_text":"- Comparison of the different density maps of functional 5-HT1A receptors during the 2 periods before the crisis, during the crisis and post-attack. Comparison of different regional cerebral blood flow maps during the 2 periods before the attack, during the attack and post-attack. Correlations of BOLD fluctuations between distant regions: functional connectivity of patients during the 2 periods before the attack, during the attack and post-attack. Variation of the BOLD signal in active period duri","definition_or_measurement_approach":"Measured using PET assessment of 5-HT1A receptor availability and MRI measures (regional cerebral blood flow, BOLD signal and functional connectivity) across pre-attack, during-attack and post-attack periods."}

France

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

19-06-2025

Processing Time Days

309

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Hospices Civils De Lyon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"fondation NEURODIS","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"fondation APICIL","duties_or_roles":"Source of monetary support","organisation_type":""}