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Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies | Clinical Trials | Clareo Health

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

Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies

NCT04457687•Eisai Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

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)

University of Alabama at Birmingham

Birmingham, Alabama, United States

David Geffen School of Medicine, UCLA Mattel Children's Hospital

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Pena

Avon, Connecticut, United States

(Resor)

Greenwich, Connecticut, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Clinical Neurosciences of Tampa Bay

Clearwater, Florida, United States

Miami Children's Hospital - Nicklaus Children's Hospital Miami

Miami, Florida, United States

Mid-Atlantic Epilepsy and Sleep Center - Bethesda

Bethesda, Maryland, United States

University of Missouri Health Care

Columbia, Missouri, United States

Key Dates

Last Updated

January 30, 2025

Conditions

Epilepsies, MyoclonicDrug Resistant Epilepsy

Interventions

Lorcaserin

DRUG

Contacts

Eisai Medical Information

CONTACT

+1-888-274-2378 esi_medinfo@eisai.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

Electroclinical Correlation of Anxiety

Temporal Interference for Drug Resistant Epilepsy

Investigating Surprise Signals in the Anterior Insula

Overnight TI in TLE