Epilepsies, MyoclonicNCT04457687
Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
A study testing Lorcaserin in people with Epilepsies, Myoclonic and Drug Resistant Epilepsy, run by Eisai Inc. at 22 sites in 2 countries.
Trial summary
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Epilepsies, Myoclonic, Drug Resistant Epilepsy
- What is being tested?
- Lorcaserin
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 22 sitesin 2 countries
- 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 2 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Dravet syndrome (according to Recommendation from a North American Consensus Panel, 2017) or other refractory epilepsy (per the judgment of the treating physician)
- Male or female, age at least 2 years at the time of informed consent
- 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
- Has a clinical benefit from lorcaserin in the opinion of the treating physician
Who cannot join
- None
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States18 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Pena
Avon, Connecticut, 06001
Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Bethesda, Maryland, 20817
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Clinical Neurosciences of Tampa Bay
Clearwater, Florida, 33764
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44106
University of Missouri Health Care
Columbia, Missouri, 65212
(Resor)
Greenwich, Connecticut, 06830
Northeastern Regional Epilepsy Group (Hackensack)
Hackensack, New Jersey, 07601
New York Medical College
Hawthorne, New York, 10532
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
David Geffen School of Medicine, UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Miami Children's Hospital - Nicklaus Children's Hospital Miami
Miami, Florida, 33155
NYU Langone Comprehensive Epilepsy Center
New York, New York, 10016
Mt. Sinai School of Medicine
New York, New York, 10029
Sidney Kimmel Medical College at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Children's National Medical Center
Washington D.C., District of Columbia, 20019
Canada4 sites
Alberta Children's Hospita
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 1C9
Children's Hospital - VH, London Health Sciences Centre
London, Ontario, N6A 4G5
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
- Conditions
- Epilepsies, Myoclonic, Drug Resistant Epilepsy
- Being tested
- Lorcaserin
- Keywords
- Extended Access Program, Expanded Access Program, Dravet Syndrome, Refractory Epilepsies, Lorcaserin
- Medical subject headings
- Epilepsies, Myoclonic, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorcaserinDrug
Also called E2023
Lorcaserin 10 milligram (mg) tablets orally.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, MyoclonicStudies 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
- NCT04457687
- Sponsor's protocol ID
- E2023-A001-405
- Status last verified
- Jan 2025
- First submitted
- 30 Jun 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies
- ClinicalTrials.gov ID
- NCT04457687
- Acronym / sponsor ID
- E2023-A001-405
- Conditions
- Epilepsies, Myoclonic, Drug Resistant Epilepsy
- Keywords
- Extended Access Program, Expanded Access Program, Dravet Syndrome, Refractory Epilepsies, Lorcaserin
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- First posted
- 7 Jul 2020 (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.
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
Study design
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of Dravet syndrome (according to Recommendation from a North American Consensus Panel, 2017) or other refractory epilepsy (per the judgment of the treating physician)
- Male or female, age at least 2 years at the time of informed consent
- 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
- Has a clinical benefit from lorcaserin in the opinion of the treating physician
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| LorcaserinAlso: E2023Lorcaserin 10 milligram (mg) tablets orally. | 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 19 Oct 2026.
Related trials for Epilepsies, Myoclonic
RecruitingPhase 1/2
ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome
Dravet Syndrome
RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
Juvenile Myoclonic Epilepsy
RecruitingPhase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
RecruitingPhase 1/2
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
Dravet Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lorcaserin in people with Epilepsies, Myoclonic and Drug Resistant Epilepsy, run by Eisai Inc. at 22 sites in 2 countries.
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 4 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 19 Oct 2026.