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Epilepsy drug study for kids halted early: what we know

NCT ID NCT05301894

Disease control Sponsor: Neurocrine Biosciences 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of a drug called NBI-827104 in children with a rare epilepsy that causes seizures during sleep. The trial was stopped early and only enrolled 19 children, so the results are limited. The main goal was to see how many children had serious 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
NBI-827104 (a drug that blocks T-type calcium channels in the brain)
What this could lead to
If successful, this could point toward a treatment option for children with this rare form of epilepsy.
What could go wrong
The study was terminated early with only 19 participants, so we have very limited data on safety or effectiveness. It is still in early testing (Phase 2).

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

4 to 12 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.

Key Inclusion Criteria: For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010: * Completed 12 weeks of treatment in Study NBI-827104-CSWS2010. For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010: * Have diagnosis of EECSWS confirmed by the Diagnosis Confirmation Panel (DCP). Key Exclusion Criteria: For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010: * Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance. For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010: * Body weight \<15 kg at Day 1. * Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator. * Presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (for example, neonatal strokes) have to be stable for at least 1 year prior to screening. * Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit. * Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before screening or plans to use such an investigational drug (other than NBI-827104) during the study. * Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.

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Conditions

The condition(s) this trial relates to.

developmental and epileptic encephalopathy developmental and/or epileptic encephalopathy with spike-wave activation in sleep epilepsy

As listed by the trial registrant

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

Continuous spike and wave during sleep Epileptic encephalopathy

Contacts and locations

Locations

  • Neurocrine Clinical Site

    Orange, California, 92868, United States

  • Neurocrine Clinical Site

    Aurora, Colorado, 80045, United States

  • Neurocrine Clinical Site

    Washington D.C., District of Columbia, 20010, United States

  • Neurocrine Clinical Site

    Miami, Florida, 33155, United States

  • Neurocrine Clinical Site

    Rochester, Minnesota, 55905, United States

  • Neurocrine Clinical Site

    Durham, North Carolina, 27705, United States

  • Neurocrine Clinical Site

    Cleveland, Ohio, 44195, United States

  • Neurocrine Clinical Site

    Dianalund, 4293, Denmark

  • Neurocrine Clinical Site

    Barcelona, 08950, Spain

  • Neurocrine Clinical Site

    Madrid, 28034, Spain

  • Neurocrine Clinical Site

    Zurich, 8032, Switzerland

  • Neurocrine Clinical Site

    London, WC1N 3JH, United Kingdom

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