Authorised Therapeutic exploratory (Phase II) Neurology

Impact of epilepsy on the brainstem adenosine pathway and its relation with arousal and respiratory reactivity BRAVE

EU CTIS ID: 2025-524511-36-00

What this study is testing

Comparing with [18F]-CPFPX PET the distribution of A1Rs in the brainstem structures involved in respiratory regulation under hypercapnic condition in patients with drug-resistant epilepsy with the one of healthy subjects.

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

Patient : Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
Patient : Aged 18 to 55 years old
Patient : Diagnosis of focal epilepsy or of idiopathic generalized epilepsy, as defined by the International League Against Epilepsy
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
Patient : Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) or generalized tonic-clonic seizure (GTCS) during the past 18 months
Patient : For women of able to procreate , use highly effective contraception until the end of relevant systemic exposure (V2)

You likely can't join if

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
Healthy subject : MRI contra-indication (presence of metallic elements, claustrophobia)
Healthy subject : Pregnant women, women in labor or breastfeeding women based on declarations at V0
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
Healthy subject : Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures
Healthy subject : Persons deprived of their liberty by a judicial or administrative decision

See the full eligibility criteria

Who can join

Patient : Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
Patient : Aged 18 to 55 years old
Patient : Diagnosis of focal epilepsy or of idiopathic generalized epilepsy, as defined by the International League Against Epilepsy
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
Patient : Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) or generalized tonic-clonic seizure (GTCS) during the past 18 months
Patient : For women of able to procreate , use highly effective contraception until the end of relevant systemic exposure (V2)
Healthy subjects : Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
Healthy subjects : Aged 18 to 55 years old
Healthy subjects : For women of childbearing potential, use highly effective contraception until the end of relevant systemic exposure (V2)

What rules you out

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
Healthy subject : MRI contra-indication (presence of metallic elements, claustrophobia)
Healthy subject : Pregnant women, women in labor or breastfeeding women based on declarations at V0
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
Healthy subject : Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures
Healthy subject : Persons deprived of their liberty by a judicial or administrative decision
Healthy subject : Adults subject to a legal protection measure (guardianship, curatorship)
Healthy subject : Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Healthy subject : Hypersensitivity to [18F]-CPFPX
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)
Patient : MRI contra-indication (presence of metallic elements, claustrophobia)
Patient :Adults subject to a legal protection measure (guardianship, curatorship)
Patient : Patient treated with vagal nerve stimulation or deep brain stimulation
Patient : Pregnant women, women in labor or breastfeeding women based on declarations at V0
Patient : Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures
Patient :Persons deprived of their liberty by a judicial or administrative decision
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
Patient : ischaemic heart disease defined as history of myocardial ischemia and/or of typical angina confirmed by a cardiologist.
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
Patient : Positive urine pregnancy test at V2, if applicable
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
Healthy Subject : Ischaemic heart disease defined as history of myocardial ischemia and/or of typical angina confirmed by a cardiologist.
Patient : Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Healthy Subject : Positive urine pregnancy test at V2, if applicable
Patient :Hypersensitivity to [18F]-CPFPX
Healthy subject : History of epilepsy
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
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
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
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)

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 all sexes, 18-64 years. The study team makes the final eligibility decision.

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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.