An Extended Access Program (EAP) for Participants Who Hav... | NCT03778424

Studies
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303

NCT03778424

Sponsor

Eisai Inc.

Status

Available

Last Update Posted

Jul 8, 2026Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Lennox Gastaut Syndrome

Interventions

Rufinamide

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 27, 2018

First Submission Date that Met QC Criteria

Dec 17, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2026

Last Update Posted Date

Jul 8, 2026Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Individual PatientsTreatment IND/Protocol

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Rufinamide	Drug	Rufinamide up to 45 milligram per kilogram per day (mg/kg/day).

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eisai Medical Information	Contact	1-888-274-2378		esi_medinfo@eisai.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Generała Tadeusza Kościuszki 52	Available	Kielce			Poland
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Condition Browse Module

MeSH Terms

ID	Term
D065768	Lennox Gastaut Syndrome
D004827	Epilepsy
D012640	Seizures
D001927	Brain Diseases

Ancestor Terms

ID	Term
D000073376	Epileptic Syndromes
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D030342	Genetic Diseases, Inborn

Browse Leaves

Not provided

Browse Branches

Not provided