BridgeMD
A PET-MRI study of serotoninergic brainstem pathway in patients with Dravet Syndrome - DRAPETONINE
EU CTIS ID: 2025-524199-40-00
What this study is testing
Comparing the [18F]-MPPF PET brainstem regional distribution of 5HT1A receptors in patients with DS with the one of patients with drug-resistant focal epilepsy
- 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
- Patients with Dravet Syndrome: Adult patients (≥ 18 but < 60 years)
- Patients with drug-resistant focal epilepsy: Patient who gave her/his written informed consent to participate to the study
- Patients with drug-resistant focal epilepsy: For women of childbearing potential, use highly effective contraception during study participation
- Healthy controls: Adult (≥ 18 years < 50 years)
- Healthy controls: Without history of neurological disorders, and/or general medical disorders
- Healthy controls: Subject who gave her/his written informed consent to participate to the study
You likely can't join if
- Patients with Dravet Syndrome: Subject in exclusion period of another study
- Patients with Dravet Syndrome: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Patients with drug-resistant focal epilepsy: Subject in exclusion period of another study
- Patients with drug-resistant focal epilepsy: MRI contra-indication (presence of metallic elements, claustrophobia)
- Patients with drug-resistant focal epilepsy: Presence of Vagal Nerve Stimulation
- Patients with drug-resistant focal epilepsy: Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor
See the full eligibility criteria
Who can join
- Patients with Dravet Syndrome: Adult patients (≥ 18 but < 60 years)
- Patients with drug-resistant focal epilepsy: Patient who gave her/his written informed consent to participate to the study
- Patients with drug-resistant focal epilepsy: For women of childbearing potential, use highly effective contraception during study participation
- Healthy controls: Adult (≥ 18 years < 50 years)
- Healthy controls: Without history of neurological disorders, and/or general medical disorders
- Healthy controls: Subject who gave her/his written informed consent to participate to the study
- Healthy controls: For women of childbearing potential, use highly effective contraception during study participation
- Patients with Dravet Syndrome: Diagnosis of Dravet syndrome will be confirmed based on medical history, type of seizures, EEG data and results of genetic testing 3. No restriction related to the seizure frequency
- Patients with Dravet Syndrome: No restriction related to the seizure frequency
- Patients with Dravet Syndrome: Patient assent and patient (or patient’s legal representative guardianship) who gave its written informed consent to participate to the study
- Patients with Dravet Syndrome: For women of childbearing potential, use highly effective contraception during study participation.
- Patients with drug-resistant focal epilepsy: Adult patient (≥ 18 years)
- Patients with drug-resistant focal epilepsy: Patient suffering from drug-resistant focal epilepsy according to ILAE classification
- Patients with drug-resistant focal epilepsy: Patient in whom presurgical evaluation is considered
- Patients with drug-resistant focal epilepsy: No restriction related to the seizure frequency
What rules you out
- Patients with Dravet Syndrome: Subject in exclusion period of another study
- Patients with Dravet Syndrome: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Patients with drug-resistant focal epilepsy: Subject in exclusion period of another study
- Patients with drug-resistant focal epilepsy: MRI contra-indication (presence of metallic elements, claustrophobia)
- Patients with drug-resistant focal epilepsy: Presence of Vagal Nerve Stimulation
- Patients with drug-resistant focal epilepsy: Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor
- Patients with drug-resistant focal epilepsy: Pregnant women, women in labor or breastfeeding women.
- Patients with drug-resistant focal epilepsy: Severe renal failure (Glomerular filtration rate < 30 ml/min)
- Patients with drug-resistant focal epilepsy: Hypersensitivity to [18F] MPPF
- Patients with drug-resistant focal epilepsy: Persons deprived of their liberty by a judicial or administrative decision
- Patients with drug-resistant focal epilepsy: Persons under psychiatric care
- Patients with Dravet Syndrome: MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition)
- Patients with drug-resistant focal epilepsy: Persons admitted to a health or social institution for purposes other than research
- Patients with drug-resistant focal epilepsy: Adults subject to a legal protection measure (guardianship, curatorship)
- Patients with drug-resistant focal epilepsy: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Healthy controls: Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)
- Healthy controls: Ongoing treatment with selective serotonin reuptake inhibitor
- Healthy controls: MRI contra-indication (presence of metallic elements, claustrophobia)
- Healthy controls: Pregnant women, women in labor or breastfeeding women.
- Healthy controls: Severe renal failure (Glomerular filtration rate < 30 ml/min)
- Healthy controls: Hypersensitivity to [18F] MPPF
- Healthy controls: Persons deprived of their liberty by a judicial or administrative decision
- Patients with Dravet Syndrome: Presence of Vagal Nerve Stimulation
- Healthy controls: Persons under psychiatric care
- Healthy controls: Persons admitted to a health or social institution for purposes other than research
- Healthy controls: Adults subject to a legal protection measure (guardianship, curatorship)
- Healthy controls: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Patients with Dravet Syndrome: Patients unable to maintain a minimul level of immobility during the imaging acquisition
- Patients with Dravet Syndrome: Pregnant women, women in labor or breastfeeding women.
- Patients with Dravet Syndrome: Severe renal failure (Glomerular filtration rate < 30 ml/min)
- Patients with Dravet Syndrome: Hypersensitivity to [18F] MPPF
- Patients with Dravet Syndrome: Persons deprived of their liberty by a judicial or administrative decision
- Patients with Dravet Syndrome: Persons under psychiatric care
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.
Explore other conditions
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.