Lennox Gastaut SyndromeNCT03778424
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
A study testing Rufinamide in people with Lennox Gastaut Syndrome, run by Eisai Inc. at 2 sites in Poland.
Trial summary
This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Lennox Gastaut Syndrome
- What is being tested?
- Rufinamide
- How many people
- Not given
- Where
- 2 sitesPoland
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Participants who were on rufinamide treatment and have completed Study E2080-G000-303 in Poland.
Who cannot join
- Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
- Available
Generała Tadeusza Kościuszki 52
Kielce
- Available
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan
About this study
Official title: An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome
This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.
- Conditions
- Lennox Gastaut Syndrome
- Being tested
- Rufinamide
- Keywords
- Central Nervous System, E2080, Rufinamide, Epilepsy, Seizures, Brain Diseases
- Medical subject headings
- Lennox Gastaut Syndrome, Epilepsy, Seizures, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RufinamideDrug
Rufinamide up to 45 milligram per kilogram per day (mg/kg/day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lennox Gastaut SyndromeStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778424
- Sponsor's protocol ID
- E2080-E044-501
- Status last verified
- Jul 2026
- First submitted
- 27 Nov 2018
- Last updated
- 8 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome
- ClinicalTrials.gov ID
- NCT03778424
- Acronym / sponsor ID
- E2080-E044-501
- Conditions
- Lennox Gastaut Syndrome
- Keywords
- Central Nervous System, E2080, Rufinamide, Epilepsy, Seizures, Brain Diseases
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.
Study design
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who were on rufinamide treatment and have completed Study E2080-G000-303 in Poland.
Key exclusion criteria (1 listed)
- Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RufinamideRufinamide up to 45 milligram per kilogram per day (mg/kg/day). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
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Not yet recruiting
Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rufinamide in people with Lennox Gastaut Syndrome, run by Eisai Inc. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eisai Medical Information (1-888-274-2378, esi_medinfo@eisai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.