Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
- Conditions
- Epilepsies, MyoclonicDrug Resistant Epilepsy
- Registration Number
- NCT04457687
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
None
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- 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
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
(Resor)
🇺🇸Greenwich, Connecticut, United States
NYU Langone Comprehensive Epilepsy Center
🇺🇸New York, New York, United States
Mt. Sinai School of Medicine
🇺🇸New York, New York, United States
Children's National Medical Center
🇺🇸Washington, 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
Sidney Kimmel Medical College at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Alberta Children's Hospita
🇨🇦Calgary, Alberta, Canada
New York Medical College
🇺🇸Hawthorne, New York, United States
Northeastern Regional Epilepsy Group (Hackensack)
🇺🇸Hackensack, New Jersey, United States
University Hospital Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada
Children's Hospital - VH, London Health Sciences Centre
🇨🇦London, Ontario, Canada