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New trial tests deep sleep vs. strong meds for hidden seizures

NCT ID NCT05263674

Disease control Sponsor: University of Southern Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether putting people into a deep sleep with strong sedatives works better than giving more seizure drugs for a serious condition called non-convulsive status epilepticus (NCSE). In NCSE, the brain has ongoing seizure activity without obvious shaking. The trial will include 140 adults who did not get better with standard treatments. Researchers will check if the seizures stop within 24 hours and track any side effects.

What this could mean

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

Active substance
Propofol (with possible low-dose Midazolam)
What this could lead to
If successful, this could establish a more effective standard treatment for a serious seizure emergency, potentially reducing brain damage and complications.
What could go wrong
This is a Phase 3 trial but still relatively small (140 participants). Deep sedation carries risks like breathing problems or infections, and the results may not apply to all patients.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

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

Started

Feb 2022

Expected to finish

Dec 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 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Adult patients (older than 18 years) with EEG-verified NCSE, according to the Salzburg criteria, who have not responded to appropriate treatment with benzodiazepines and at least one 2nd line i.v. anti-seizure medication according to the current Danish national neurological treatment guidelines (Levetiracetam, Fosfenytoin or Valproate). Exclusion Criteria: * patients with epilepticus status due to acute neuroinfection (e.g. bacterial meningitis or viral encephalitis) * acute traumatic or spontaneous intracranial hemorrhage * suspicion of cerebral anoxia / hypoxia / hypoglycemia / epileptic encephalopathy * contraindications to anti-seizure medication defined in the protocol * contraindications to anesthesia treatment in intensive care * focal motor status epilepticus without relevant conscious influence (Glasgow Coma Scale\> 13) * known epileptic encephalopathy * Clinical need for acute intubation

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Conditions

The condition(s) this trial relates to.

Status Epilepticus

As listed by the trial registrant

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

Non-convulsive status epilepticus

How to take part

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

  1. The places running it

    5 sites. 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

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Department of Neurology

    RECRUITING

    Herlev, 2730, Denmark

  • Odense University Hospital

    RECRUITING

    Odense, 5000, Denmark

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • University Hospital of Zealand

    RECRUITING

    Roskilde, 4000, Denmark

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