ClinicalTrials.gg
No longer availableNCT04457687Updated Oct 19, 2026

Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies

An expanded access record providing Lorcaserin in Epilepsies, Myoclonic and Drug Resistant Epilepsy, sponsored by Eisai Inc.. No longer available at 22 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Eisai Inc. · Expanded access

Updated Oct 19, 2026Now No longer available1 site added+1 moreGo to Updates ↓

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Study type
Expanded access
Access type
Intermediate-size population
Ages
2 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 61 studies in Epilepsies, Myoclonic with a site in United States — 11 open to participants now, 17 under way, 4 of them phase 3. Epilepsies, Myoclonic · United States.

Other kind
7 of 61
none open now
Registered
33rd of 61
by date
Lead sponsor
2 of 61
Eisai Inc.

Among the 61 studies in Epilepsies, Myoclonic with a site in United States, this one is one of 7 of another kind, and was the 33rd registered.

Epilepsies, Myoclonic

92 studies on the registry are indexed under Epilepsies, Myoclonic; 21 are open to participants now.

Browse Epilepsies, Myoclonic studies →

Open to participants now

11 of the 61 studies in Epilepsies, Myoclonic with a site in United States are open now. Recruiting first, the newest first:

6 more — sign in →

All 11 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 14 Epilepsies, Myoclonic studies recruiting now, 3 (21%) set no upper age limit and 10 (71%) stop at 75 or younger; 11 take children under 18; 3 take healthy volunteers.

This study: 2 Years and older · all sexes.

The full table on the hub →

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02

Study summary

The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.

03

Conditions studied

  • Epilepsies, Myoclonic
  • Drug Resistant Epilepsy

Keywords

  • Extended Access Program
  • Expanded Access Program
  • Dravet Syndrome
  • Refractory Epilepsies
  • Lorcaserin
04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Confirmed diagnosis of Dravet syndrome (according to Recommendation from a North American Consensus Panel, 2017) or other epilepsy (per the judgment of the treating physician)
  2. Male or female, age at least 2 years at the time of
  3. Currently treated with lorcaserin, that the treatment is for Dravet syndrome or other refractory epilepsies, and the treatment was initiated before 13 Feb 2020; or has completed Study E2023-A001-304
  4. Has a clinical benefit from lorcaserin in the opinion of the treating physician

Exclusion criteria

Exclusion Criteria:

None

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • Lorcaserin 10 milligram (mg) tablets orally.

    Also known as: E2023

06

Where to request access

22 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
  • David Geffen School of Medicine, UCLA Mattel Children's Hospital
    Los Angeles, California 90095, United States
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • Pena
    Avon, Connecticut 06001, United States
  • (Resor)
    Greenwich, Connecticut 06830, United States
  • Children's National Medical Center
    Washington D.C., District of Columbia 20019, United States
  • Clinical Neurosciences of Tampa Bay
    Clearwater, Florida 33764, United States
  • Miami Children's Hospital - Nicklaus Children's Hospital Miami
    Miami, Florida 33155, United States
  • Mid-Atlantic Epilepsy and Sleep Center - Bethesda
    Bethesda, Maryland 20817, United States
  • University of Missouri Health Care
    Columbia, Missouri 65212, United States
  • Northeastern Regional Epilepsy Group (Hackensack)
    Hackensack, New Jersey 07601, United States
  • New York Medical College
    Hawthorne, New York 10532, United States
  • NYU Langone Comprehensive Epilepsy Center
    New York, New York 10016, United States
  • Mt. Sinai School of Medicine
    New York, New York 10029, United States
  • University Hospital Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Sidney Kimmel Medical College at Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania 15224, United States
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • Alberta Children's Hospita
    Calgary, Alberta T3B 6A8, Canada
  • Stollery Children's Hospital
    Edmonton, Alberta T6G 1C9, Canada
  • BC Children's Hospital
    Vancouver, British Columbia V6H 3N1, Canada
  • Children's Hospital - VH, London Health Sciences Centre
    London, Ontario N6A 4G5, Canada
07

Updates

1 registry update since Sep 25, 2026
Status
Available→No longer available
changed Oct 19, 2026
Sites
1 site added, 1 site removed
Show site
  • Children's National Medical Center · Washington D.C., United States
Show 1 removed
  • Children's National Medical Center · Washington, United States
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Available→No longer available
    1 site added, 1 site removed
    Show site
    • Children's National Medical Center · Washington D.C., United States
    Show 1 removed
    • Children's National Medical Center · Washington, United States
    + 2 other changes: index terms and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

08

Registry details

Key details

Study ID
NCT04457687
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Jul 7, 2020
Last update
Oct 19, 2026
View the source record on ClinicalTrials.gov ↗

Requesting access

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No contact was published for this record. The registry link below has the sponsor’s details.

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