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Lifeline for kids with severe epilepsy: drug access extended

NCT ID NCT03778424

Disease control Sponsor: Eisai Inc. 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 Results may not be published yet.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
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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This program offers continued access to rufinamide for children with Lennox-Gastaut syndrome, a severe form of epilepsy, who completed a previous study. The goal is to keep providing the medication until it becomes commercially available in Poland. Only children who were already taking rufinamide in the earlier study can join.

What this could mean

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

Active substance
rufinamide
What this could lead to
If successful, this program ensures children with hard-to-control seizures can keep taking rufinamide without interruption until it is commercially available.
What could go wrong
This is an access program, not a new test of effectiveness. It only includes children who already tolerated the drug, so 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.

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 years and older

Sex

Anyone

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: * Participants who were on rufinamide treatment and have completed Study E2080-G000-303 in Poland. Exclusion Criteria: * Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.

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Conditions

The condition(s) this trial relates to.

brain disorder epilepsy Lennox-Gastaut syndrome visual epilepsy

As listed by the trial registrant

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

Lennox-Gastaut syndrome

How to take part

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

  1. The places running it

    2 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

  • Generała Tadeusza Kościuszki 52

    AVAILABLE

    Kielce, Poland

  • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

    AVAILABLE

    Poznan, Poland

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