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

NCT04457687 — No longer available, Eisai Inc.
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Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies

RegistryNCT04457687
StatusNo longer available
Study typeExpanded access
SponsorEisai Inc. (Industry)
ConditionsEpilepsies, Myoclonic, Drug Resistant Epilepsy
InterventionsLorcaserin (Drug)
Datesfirst posted 2020-07-07, last updated 2026-10-19
Locations22 sites in United States, Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Epilepsies, Myoclonic All trials for Drug Resistant Epilepsy All trials of Lorcaserin

-Summary

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

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+Arms and interventions

  • Lorcaserin (Drug), also known as E2023: Lorcaserin 10 milligram (mg) tablets orally.

+Eligibility

Sex: All, ages: 2 Years to any

Inclusion Criteria:

1. 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)
2. Male or female, age at least 2 years at the time of informed consent
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:

None

+Locations (22)

FacilityCityCountryStatus
University of Alabama at BirminghamBirmingham, AlabamaUnited States
David Geffen School of Medicine, UCLA Mattel Children's HospitalLos Angeles, CaliforniaUnited States
Children's Hospital ColoradoAurora, ColoradoUnited States
PenaAvon, ConnecticutUnited States
(Resor)Greenwich, ConnecticutUnited States
Children's National Medical CenterWashington D.C., District of ColumbiaUnited States
Clinical Neurosciences of Tampa BayClearwater, FloridaUnited States
Miami Children's Hospital - Nicklaus Children's Hospital MiamiMiami, FloridaUnited States
Mid-Atlantic Epilepsy and Sleep Center - BethesdaBethesda, MarylandUnited States
University of Missouri Health CareColumbia, MissouriUnited States
Northeastern Regional Epilepsy Group (Hackensack)Hackensack, New JerseyUnited States
New York Medical CollegeHawthorne, New YorkUnited States
NYU Langone Comprehensive Epilepsy CenterNew York, New YorkUnited States
Mt. Sinai School of MedicineNew York, New YorkUnited States
University Hospital Cleveland Medical CenterCleveland, OhioUnited States
Sidney Kimmel Medical College at Thomas Jefferson UniversityPhiladelphia, PennsylvaniaUnited States
Children's Hospital of Pittsburgh of UPMCPittsburgh, PennsylvaniaUnited States
The University of Texas Health Science Center at HoustonHouston, TexasUnited States
Alberta Children's HospitaCalgary, AlbertaCanada
Stollery Children's HospitalEdmonton, AlbertaCanada
BC Children's HospitalVancouver, British ColumbiaCanada
Children's Hospital - VH, London Health Sciences CentreLondon, OntarioCanada