Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT07249034
Eligibility Criteria:
Inclusion Criteria:
* For patients
1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
2. Aged 18 to 55 years old
3. Diagnosis of focal epilepsy or of idiopathic generalized epilepsy, as defined by the International League Against Epilepsy
4. Diagnosis of refractory epilepsy, as defined by the International League Against Epilepsy
5. Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) during the past 18 months
6. For women of childbearing potential, use effective contraception during study participation
* For healthy volunteers
1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
2. Aged 18 to 55 years old
3. For women of childbearing potential, use effective contraception during study participation
Exclusion Criteria:
* For patients
1. Ongoing or chronic respiratory and/or cardiac insufficiency
2. Obstructive sleep-apnea syndrome
3. Ongoing treatment with selective serotonin reuptake inhibitor
4. MRI contra-indication (presence of metallic elements, claustrophobia)
5. Patient treated with vagal nerve stimulation or deep brain stimulation
6. Pregnant women, women in laboror breastfeeding women, based on declarations at V0
7. Persons under psychiatric care
8. Persons deprived of their liberty by a judicial or administrative decision
9. Adults subject to a legal protection measure (guardianship, curatorship)
10. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
11. Positive urine pregnancy test at V2, if applicable
12. Hypersensitivity to \[18F\]-CPFPX
* For healthy volunteers
1. History of epilepsy
2. Ongoing or chronic respiratory and/or cardiac insufficiency
3. Obstructive sleep-apnea syndrome
4. Ongoing treatment with selective serotonin reuptake inhibitor
5. MRI contra-indication (presence of metallic elements, claustrophobia)
6. Pregnant women, women in labor or breastfeeding women, based on declarations at V0
7. Persons under psychiatric care
8. Persons deprived of their liberty by a judicial or administrative decision
9. Adults subject to a legal protection measure (guardianship, curatorship)
10. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
11. Positive urine pregnancy test at V2, if applicable
12. Hypersensitivity to \[18F\]-CPFPX
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07249034
Study Brief:
Protocol Section:
NCT07249034