[18F]CPFPX for Drug-resistant epilepsy | Focal epilepsy | Idiopathic generalized epilepsy | Generalized convulsive epilepsy

Inclusion criteria

• {"criterion_text":"- Patient : Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study\n- Patient : Aged 18 to 55 years old\n- Patient : Diagnosis of focal epilepsy or of idiopathic generalized epilepsy, as defined by the International League Against Epilepsy\n- Patient : Diagnosis of refractory epilepsy, as defined by the International League Against Epilepsy as failure of adequate trials of two tolerated, appropriately chosen and used antiseizure drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom52\n- Patient : Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) or generalized tonic-clonic seizure (GTCS) during the past 18 months\n- Patient : For women of able to procreate , use highly effective contraception until the end of relevant systemic exposure (V2)\n- Healthy subjects : Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study\n- Healthy subjects : Aged 18 to 55 years old\n- Healthy subjects : For women of childbearing potential, use highly effective contraception until the end of relevant systemic exposure (V2)"}

Exclusion criteria

• {"criterion_text":"- Patient : Ongoing or chronic respiratory insufficiency defined as breathlessness Grade ≥ 2 using the modified Medical Research Council Dyspnea Scale and/or patient treated by a pneumologist for respiratory insufficiency\n- Healthy subject : MRI contra-indication (presence of metallic elements, claustrophobia)\n- Healthy subject : Pregnant women, women in labor or breastfeeding women based on declarations at V0\n- Patient : Obstructive sleep-apnea syndrome defined as participant who had been diagnosed for Obstructive sleep apnoea by polysomnography, whether a dedicated therapy is ongoing or not\n- Healthy subject : Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures\n- Healthy subject : Persons deprived of their liberty by a judicial or administrative decision\n- Healthy subject : Adults subject to a legal protection measure (guardianship, curatorship)\n- Healthy subject : Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n- Healthy subject : Hypersensitivity to [18F]-CPFPX\n- Patient : Hypercapnic challenges contra-indication (History of stroke in the last 5 years, space‐occupying lesion in the brain associated with brain oedema and/or mass effect on MRI/CT scan)\n- Patient : MRI contra-indication (presence of metallic elements, claustrophobia)\n- Patient :Adults subject to a legal protection measure (guardianship, curatorship)\n- Patient : Patient treated with vagal nerve stimulation or deep brain stimulation\n- Patient : Pregnant women, women in labor or breastfeeding women based on declarations at V0\n- Patient : Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures\n- Patient :Persons deprived of their liberty by a judicial or administrative decision\n- Patient : Cardiac insufficiency defined as symptoms Grade ≥ 2 using New York Heart Association Functional Classification and/or patient treated by a cardiologist for chronic heart failure\n- Patient : ischaemic heart disease defined as history of myocardial ischemia and/or of typical angina confirmed by a cardiologist.\n- PAtient : Ongoing treatment with selective serotonin reuptake inhibitor (Selective Serotonin Reuptake Inhibitors) : Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) : Duloxetine, Milnacipran, Venlafaxine\n- Patient : Positive urine pregnancy test at V2, if applicable\n- Healthy subject : Cardiac insufficiency defined as symptoms Grade ≥ 2 using New York Heart Association Functional Classification and/or patient treated by a cardiologist for chronic heart failure\n- Healthy Subject : Ischaemic heart disease defined as history of myocardial ischemia and/or of typical angina confirmed by a cardiologist.\n- Patient : Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n- Healthy Subject : Positive urine pregnancy test at V2, if applicable\n- Patient :Hypersensitivity to [18F]-CPFPX\n- Healthy subject : History of epilepsy\n- Healthy subject : Ongoing or chronic respiratory insufficiency defined as breathlessness Grade ≥ 2 using the modified Medical Research Council Dyspnea Scale and/or patient treated by a pneumologist for respiratory insufficiency\n- Healthy subject : Obstructive sleep-apnea syndrome defined as participant who had been diagnosed for Obstructive sleep apnoea by polysomnography, whether a dedicated therapy is ongoing or not\n- Healthy subject : Ongoing treatment with selective serotonin reuptake inhibitor : : SSRIs (Selective Serotonin Reuptake Inhibitors) : Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) : Duloxetine, Milnacipran, Venlafaxine\n- Healthy subject : Hypercapnic challenges contra-indication (History of stroke in the last 5 years, space‐occupying lesion in the brain associated with brain oedema and/or mass effect on MRI/CT scan)"}

Primary endpoints

• {"endpoint_text":"- Comparison of the [18F]-CPFPX BPND in the brainstem structures involved in respiratory regulation under hypercapnic condition in patients with drug-resistant epilepsy with the one of healthy subjects","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Comparison of the [18F]-CPFPX BPND in the cortical structures involved in respiratory regulation under hypercapnic condition in patients with drug-resistant epilepsy with the one of healthy subjects","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluating the relation between [18F]-CPFPX BPND in the brainstem structures involved in respiratory regulation under hypercapnic condition and the HCVR slope in patients with drug-resistant epilepsy and in healthy subjects","definition_or_measurement_approach":""}
• {"endpoint_text":"- Comparison of the HCVR slope in patients with drug-resistant epilepsy and in heathly subjects","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluating the relation between the HCVR slope and the pattern of BOLD activiation during BH in patients with drug-resistant epilepsy and in heathly subjects","definition_or_measurement_approach":""}
• {"endpoint_text":"- Comparing brainstem regional volumes on MRI of patients with drug-resistant epilepsy with the one of healthy subjects","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluating the relation between the brainstem regional volumes on MRI and the HCVR slope in patients with drug-resistant epilepsy and in heathly subjects","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluating the relation between mean daily intake of caffeine (mg/day) and the [18F]-CPFPX BPND in the brainstem and cortical structures","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

03-03-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

58

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Hospices Civils De Lyon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France