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New brain scans aim to uncover why dravet patients face higher sudden death risk

NCT ID NCT07013331

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study uses PET and MRI scans to look at serotonin pathways in the brainstem of adults with Dravet syndrome, a severe form of epilepsy. Researchers want to see if these pathways are different in Dravet patients compared to those with other drug-resistant epilepsy and healthy people. The goal is to better understand why Dravet syndrome carries a high risk of sudden unexpected death in epilepsy (SUDEP). The study involves 30 participants: 10 with Dravet syndrome, 10 with focal epilepsy, and 10 healthy volunteers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Patients with DS * Inclusion criteria 1. Adult patients (≥ 18 but \< 60 years) 2. 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 4. Patient assent and patient (or patient's legal representative guardianship) who gave its written informed consent to participate to the study 5. For women of childbearing * Exclusion criteria 1. Subject in exclusion period of another study 2. MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition) 3. Presence of Vagal Nerve Stimulation 4. Patients unable to maintain a minimul level of immobility during the imaging acquisition 5. Pregnant women, women in labor or breastfeeding women. 6. Severe renal failure (Glomerular filtration rate \< 30 ml/min) 7. Hypersensitivity to \[18F\] MPPF 8. Persons deprived of their liberty by a judicial or administrative decision 9. Persons under psychiatric care 10. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme Patients with drug-resistant focal epilepsy * Inclusion criteria 1. Adult patient (≥ 18 years) 2. Patient suffering from drug-resistant focal epilepsy according to ILAE classification 3. Patient in whom presurgical evaluation is considered 4. No restriction related to the seizure frequency 5. Patient who gave her/his written informed consent to participate to the study 6. For women of childbearing potential, use highly effective contraception during study participation * Exclusion criteria 1. Subject in exclusion period of another study 2. MRI contra-indication (presence of metallic elements, claustrophobia) 3. Presence of Vagal Nerve Stimulation 4. Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor 5. Pregnant women, women in labor or breastfeeding women. 6. Severe renal failure (Glomerular filtration rate \< 30 ml/min) 7. Hypersensitivity to \[18F\] MPPF 8. Persons deprived of their liberty by a judicial or administrative decision 9. Persons under psychiatric care 10. Persons admitted to a health or social institution for purposes other than research 11. Adults subject to a legal protection measure (guardianship, curatorship) 12. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme Healthy controls * Inclusion criteria 1. 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) 2. Ongoing treatment with selective serotonin reuptake inhibitor 3. MRI contra-indication (presence of metallic elements, claustrophobia) 4. Pregnant women, women in labor or breastfeeding women. 5. Severe renal failure (Glomerular filtration rate \< 30 ml/min) 6. Hypersensitivity to \[18F\] MPPF 7. Persons deprived of their liberty by a judicial or administrative decision 8. Persons under psychiatric care 9. Persons admitted to a health or social institution for purposes other than research 10. Adults subject to a legal protection measure (guardianship, curatorship) 11. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme * Exclusion criteria 1. 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) 2. Ongoing treatment with selective serotonin reuptake inhibitor 3. MRI contra-indication (presence of metallic elements, claustrophobia) 4. Pregnant women, women in labor or breastfeeding women. 5. Severe renal failure (Glomerular filtration rate \< 30 ml/min) 6. Hypersensitivity to \[18F\] MPPF 7. Persons deprived of their liberty by a judicial or administrative decision 8. Persons under psychiatric care 9. Persons admitted to a health or social institution for purposes other than research 10. Adults subject to a legal protection measure (guardianship, curatorship) 11. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Drug Resistant Epilepsy Epilepsies, Myoclonic epilepsy focal epilepsy Sudden Unexpected Death in Epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Neurologique Pierre Wertheimer

    RECRUITING

    Bron, Rhone, 69500, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.