ClinicalTrials.gov record NCT07013331

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 60 years old
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This study compares PET‑MRI images of the brainstem serotonin pathway in three adult groups: people with Dravet syndrome, people with drug‑resistant focal epilepsy being considered for presurgical evaluation, and healthy adults. Each participant has an eligibility visit and a PET‑MRI scan with injection of the tracer [18F]‑MPPF; imaging includes a dynamic emission scan lasting about 90 minutes. The study will recruit about 10 people in each group; individual participation lasts roughly 2 to 8 weeks.

What it is studying. Whether adults with Dravet syndrome show measurable differences in the brainstem serotonin (5‑HT) pathway on PET‑MRI compared with people who have drug‑resistant focal epilepsy and with healthy adults, and how those imaging measures relate to measures such as central sleep apnea and brainstem volume.

What the researchers hope to learn. To determine whether PET‑MRI with [18F]‑MPPF detects alterations in the brainstem serotonin system in adults with Dravet syndrome; to compare those findings with drug‑resistant focal epilepsy and healthy adults; to examine links between PET measures, brainstem volumes, and central sleep apnea; and to provide data for future research on mechanisms related to seizure‑related respiratory dysfunction.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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. 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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • [18F]MPPF PET-MRI

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Patients with DS
  • 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
  • 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
  • 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
  • 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
  • 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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will attend an initial visit for eligibility review, medical history and a clinical exam; women of childbearing age will have a urine pregnancy test before imaging. Within 2 to 8 weeks you will undergo a combined PET‑MRI visit: anatomical MRI is acquired first, then an IV injection of the radioactive tracer [18F]MPPF and a dynamic PET scan over about 90 minutes. Patients with Dravet syndrome will have additional sleep monitoring (24‑hour recording) to measure central sleep apneas and MR-based brain volume analyses will be performed. The PET‑MRI requires remaining still in the scanner and may be difficult for people with claustrophobia or who cannot keep still.

How the study is structured. Non‑randomized interventional study with three parallel groups (Dravet syndrome, drug‑resistant focal epilepsy, healthy controls). Participants have an initial eligibility visit, then a PET‑MRI visit within 2–8 weeks in which anatomical MRI is done first, followed by an intravenous injection of the tracer [18F]‑MPPF and a dynamic PET scan lasting about 90 minutes. Some study measures include a 24‑hour sleep assessment (for central sleep apnea) and brain volume comparisons. There is no masking (open label).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Dravet syndrome

This trial is also listed on this site under CDKL5 deficiency disorder.

Clinical trials22 trials listed for Dravet syndromeEvery trial the registry lists for Dravet syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Dravet syndrome researchLatest monthly update: September 2026. Includes: CBD in practice. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 4, 2026
Primary completion
Jan 4, 2028 (estimated)
Study completion
Jan 4, 2028 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
May 8, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Hospices Civils de Lyon

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
assent
A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
legal representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
women of childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
Inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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