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Blood biomarkers may flag epilepsy patients at risk of sudden death

NCT ID NCT03419000

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether tiny molecules in the blood, called microRNAs, can identify epilepsy patients who have dangerous drops in oxygen during seizures. Researchers compared 50 drug-resistant epilepsy patients undergoing video-EEG monitoring, splitting them into those who had breathing problems during seizures and those who did not. The goal is to find a simple blood test that could predict risk of sudden unexpected death in epilepsy (SUDEP).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a blood test that identifies epilepsy patients at higher risk of sudden unexpected death (SUDEP), enabling closer monitoring or preventive strategies.
What could go wrong
This is a small, early-stage observational study (75 participants) looking at biomarkers, not a treatment trial. The findings may not translate into a reliable clinical test or reduce SUDEP risk.

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

75 people

The number who actually took part.

Started

Mar 2018

Finished

Mar 2022

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 years and older

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.

Inclusion Criteria: For the patients : * Adult patient (≥ 18 years) suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification * Patient undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure * Patient who gave her/his written informed consent to participate to the study * Patient affiliated to the French health care system For the healthy volunteers : * Adult (≥ 18 years) * Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders * Subject who gave her/his written informed consent to participate to the study * Subject affiliated to the French health care system Exclusion Criteria: For the patients : * Ongoing major depressive episode as defined by a score ≥ 15 at the French version of the NDDI-E scale\* * Current panic disorder as defined by a score ≥ 7 at the French version of the GAD-7 scale\* * Ongoing treatment with selective serotonin reuptake inhibitor * Patient who benefit from a protective measure For the healthy volunteers : * 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 * Subjects with these psychiatric comorbidities and/or treatment will be excluded in order to limit risk that the relation previously reported between miR-135a, miR-16, miR-1202 and depression and/or panic disorder and/or response to selective serotonin

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Conditions

The condition(s) this trial relates to.

disease Drug Resistant Epilepsy focal epilepsy generalized epilepsy

As listed by the trial registrant

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

Drug resistant epilepsy

Contacts and locations

Locations

  • Hospices Civils de Lyon

    Bron, 69500, France

  • Service de Neurophysiologie Clinique Hôpital La Timone

    Marseille, 13005, France

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