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
1 other identifier
expanded_access
N/A
2 countries
22
Brief Summary
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedJanuary 30, 2025
January 1, 2025
June 30, 2020
January 28, 2025
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (22)
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