Taking people in FranceNo phase

Studies brain serotonin signaling in adults with Dravet syndrome using PET-MRI imaging

Uses PET-MRI brain imaging to study serotonin pathways in adults with Dravet syndrome.

Key facts

Who runs it: Hospices Civils de Lyon
Where: Bron, FranceSee the site
Trial code: NCT07013331
Registry title: A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome
Status: Recruiting
People taking part: 30 people, planned
Started: 4 May 2026
Expected to end: 4 Jan 2028
Type of study: Interventional, 3 groups
Treatments tested: [18F]MPPF PET-MRI
Record updated: 8 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for three groups of adults: people with Dravet syndrome, people with drug-resistant focal epilepsy, and healthy volunteers. Everyone has a PET-MRI brain scan to study the serotonin pathway in the brainstem.

Age: Adults aged 18 years or older. The record lists a maximum age of 60 years, and the Dravet syndrome group is under 60.
Sex: All sexes can join.
Disease stage: Dravet syndrome confirmed by medical history, seizure type, EEG and genetic testing, with no limit on seizure frequency. Or drug-resistant focal epilepsy where surgery evaluation is being considered, with no limit on seizure frequency.
Earlier treatment: People with focal epilepsy cannot join if they are on serotonin treatment, including SSRI antidepressants. Healthy volunteers cannot join if they are on an SSRI.
Biomarker or test result: Dravet syndrome is confirmed with genetic testing. The record does not name a specific gene result as a requirement.

Main reasons for not taking part

Cannot have an MRI (metal in the body, claustrophobia, cannot stay still)
Has a vagus nerve stimulator (Dravet and focal epilepsy groups)
Pregnant, in labor or breastfeeding
Severe kidney failure (filtration rate below 30 ml/min)
Allergy to [18F] MPPF

The registry criteria, word for word

Show all 7 criteriaShow less

Other criteria

Patients with DS
Inclusion criteria; Adult patients (≥ 18 but < 60 years); Diagnosis of Dravet syndrome will be confirmed based on medical history, type of seizures, EEG data and results of genetic testing; No restriction related to the seizure frequency; Patient assent and patient (or patient's legal representative guardianship) who gave its written informed consent to participate to the study; For women of childbearing
Exclusion criteria; Subject in exclusion period of another study; MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition); Presence of Vagal Nerve Stimulation; Patients unable to maintain a minimul level of immobility during the imaging acquisition; Pregnant women, women in labor or breastfeeding women; Severe renal failure (Glomerular filtration rate < 30 ml/min); Hypersensitivity to [18F] MPPF; Persons deprived of their liberty by a judicial or administrative decision; Persons under psychiatric care; Persons not affiliated to a social security scheme or beneficiaries of a similar scheme; Patients with drug-resistant focal epilepsy
Inclusion criteria; Adult patient (≥ 18 years); Patient suffering from drug-resistant focal epilepsy according to ILAE classification; Patient in whom presurgical evaluation is considered; No restriction related to the seizure frequency; Patient who gave her/his written informed consent to participate to the study; For women of childbearing potential, use highly effective contraception during study participation
Exclusion criteria; Subject in exclusion period of another study; MRI contra-indication (presence of metallic elements, claustrophobia); Presence of Vagal Nerve Stimulation; Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor; Pregnant women, women in labor or breastfeeding women; Severe renal failure (Glomerular filtration rate < 30 ml/min); Hypersensitivity to [18F] MPPF; Persons deprived of their liberty by a judicial or administrative decision; Persons under psychiatric care; Persons admitted to a health or social institution for purposes other than research; Adults subject to a legal protection measure (guardianship, curatorship); Persons not affiliated to a social security scheme or beneficiaries of a similar scheme; Healthy controls
Inclusion criteria; 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); Ongoing treatment with selective serotonin reuptake inhibitor; MRI contra-indication (presence of metallic elements, claustrophobia); Pregnant women, women in labor or breastfeeding women; Severe renal failure (Glomerular filtration rate < 30 ml/min); Hypersensitivity to [18F] MPPF; Persons deprived of their liberty by a judicial or administrative decision; Persons under psychiatric care; Persons admitted to a health or social institution for purposes other than research; Adults subject to a legal protection measure (guardianship, curatorship); Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Exclusion criteria; 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); Ongoing treatment with selective serotonin reuptake inhibitor; MRI contra-indication (presence of metallic elements, claustrophobia); Pregnant women, women in labor or breastfeeding women; Severe renal failure (Glomerular filtration rate < 30 ml/min); Hypersensitivity to [18F] MPPF; Persons deprived of their liberty by a judicial or administrative decision; Persons under psychiatric care; Persons admitted to a health or social institution for purposes other than research; Adults subject to a legal protection measure (guardianship, curatorship); Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 60 years old?

Where in France

Hôpital Neurologique Pierre WertheimerBron, FranceContact: Sylvain Rheims, PrTaking people

About the trial

What the trial wants to find out

Dravet Syndrome (DS) is a severe neurodevelopmental disease, which is predominantly caused by mutations of SCN1A, the gene coding for Nav1.1 voltage-gated sodium channels. DS is characterized by infancy onset, severe cognitive deficit and drug-resistant seizures, including several generalized convulsive seizures per day and frequent status epilepticus, often triggered by fever or hyperthermia. Among the causes of premature deaths in patients with epilepsy, sudden and unexpected death in epilepsy (SUDEP) represents a major cause. SUDEP is a non-traumatic and non-drowning death in patients with epilepsy, unrelated to a documented status epilepticus. The risk of SUDEP is particularly high in patients suffering from DS, reaching about 9/1000-person-year, as compared to about 1/1000-person-year in people with epilepsy including all disease types. The main clinical risk factor of SUDEP is the frequency of convulsive seizures. Beyond improving seizure control, which we showed to mitigate the SUDEP risk, more specific preventive treatment strategies are still lacking.

Read full original descriptionShow less

Experimental and clinical data suggest that most SUDEP cases result from postictal brainstem dysfunction, including central respiratory arrest There is a body of evidence suggesting involvement of serotonin (5HT) dysfunction both in the pathogenesis of epilepsy in DS and in seizure-related respiratory dysfunction. Serotonin indeed plays a key role in the regulation of respiration. Population firing of serotoninergic neurons in the medullary raphe is significantly decreased during the ictal and post-ictal periods, in association with decreased breathing and heart rate during and after seizures. Most importantly, post-mortem data in patients, including DS, showed alteration of neuronal populations in the medulla in SUDEP cases with evidence for greater reduction in neuromodulatory neuropeptidergic and monoaminergic, including serotoninergic, systems.

SUDEP in DS might therefore be the result of a seizure-induced fatal apnea in a patient who has developed epilepsy-related vulnerability to central respiratory dysfunction favored by 5HT dysfunction. However, several issues remain to be addressed to identify detailed mechanisms and effective therapies. Among them, a key issue is the exact relation between the alterations of the 5HT pathway observed in DS and epilepsy-related respiratory dysfunction

In the present study, the hypothesis is that adult patients with DS might demonstrate specific alterations of the 5HT pathway within the brainstem as assessed by PET imaging. The DRAPETOTINE study will thus focus on imaging 5HT brainstem pathway with PET and MRI in patients with DS to assess if abnormalities can be observed and through comparison with data collected in patients drug-resistant focal epilepsy whether these abnormalities are DS specficic or reflect the consequence on brainstem 5HT pathway of refractory seizures.

This study will involve 20 adult patients, including 10 adults with established diagnosis of Dravet Syndrome and 10 patients with drug-resistant focal epilepsy. Ten healthy adults will also be included. Participants will be recruited over a period of 18 months and the duration of participation for each participant will be 2 weeks to 8 weeks

The 3 groups in the trial

Patients with Dravet syndromeTreatment being tested
Adult patients with Dravet syndrome (\> 18 and \< 60 years). Diagnosis of Dravet syndrome will be confirmed based on medical history, type of seizures, EEG data and results of genetic testing. Ten DS patients will be recruited and will be passed the PET-IRM with injection of the tracer \[18F\]MPPF.
Treatment: [18F]MPPF PET-MRI
Patients with drug-resistant focal epilepsyTreatment being tested
Adult patients (\> 18 years) with drug-resistant focal epilepsy, as defined by the ILAE, and whom presurgical evaluation is considered. Ten patients will be recruited and will be passed the PET-IRM with injection of the tracer \[18F\]MPPF.
Treatment: [18F]MPPF PET-MRI
Adult healthy controls (> 18 years)Treatment being tested
Ten healthy controls will be recruited and will be passed the PET-IRM with injection of the tracer \[18F\]MPPF. Participants must be of legal age.
Treatment: [18F]MPPF PET-MRI

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record

ClinicalTrials.gov NCT07013331

Listed on ClinicalTrials.gov.

Official title

A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome

Plain-language title

Studies brain serotonin signaling in adults with Dravet syndrome using PET-MRI imagingGenerated from the registry record. The registry title is the official one.

AI summary

From the trial's eligibility criteria. Read by machine on 12 November 2026.

Fit questions

Built from NCT07013331, who can take part

Record updated

8 May 2026