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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

28 Feb 2022 → ongoing

Decision date (initial)

2024-09-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

fondation NEURODIS · fondation APICIL

External identifiers

EU CT number

2024-513873-36-00

EudraCT number

2021-000209-25

ClinicalTrials.gov

NCT05084469

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 6

1. With PET data: 1. Evaluation of the availability of 5-HT1A receptors in patients during active periods in the crisis and inter-crisis phase;
2. With PET data: 2. Evaluation of the difference in density of functional 5-HT1A receptors of patients during an inactive period compared to controls
3. With PET data Evaluation of the difference in density of functional 5-HT1A receptors of patients in active period in crisis and inter-crisis phase compared to the control group.
4. With MRI data: 4. Evaluation of brain activity in patients during active periods in seizure and inter-seizure phases (activation fMRI)
5. With MRI data: 5. Comparison of cerebral perfusion and functional connectivity networks (fMRI) between patients in an inactive period compared to the control group;
6. With MRI data: 6. Comparison of cerebral perfusion and functional connectivity networks (fMRI) in active patients in the seizure and inter-seizure phase and compared to the control group.

Conditions and MedDRA coding

Nervous System Diseases

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

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

Exclusion criteria 7

1. 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
2. • Patients already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation
3. 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;
4. •Patients with a contraindication to [18F]F13640 PET examinations: hypersensitivity to the active substance or to one of the excipients (sodium chloride);
5. 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;
6. Patients presenting an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc.) judged by the investigator;
7. • Patients who have exceeded the annual amount of compensation authorized for participation in research protocols

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Genevieve DEMARQUAY

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Genevieve DEMARQUAY

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications