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

Available (expanded access)

Conditions studied: Epilepsies, Myoclonic, Drug Resistant Epilepsy

In brief

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

Key facts

Study ID

NCT04457687

Run by

Eisai Inc.

Last updated by the study team

2025-01-30

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Northeastern Regional Epilepsy Group (Hackensack) — Hackensack, New Jersey, United States
• New York Medical College — Hawthorne, New York, United States
• NYU Langone Comprehensive Epilepsy Center — New York, New York, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• University Hospital Cleveland Medical Center — Cleveland, Ohio, 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
• Stollery Children's Hospital — Edmonton, Alberta, Canada
• BC Children's Hospital — Vancouver, British Columbia, Canada
• Children's Hospital - VH, London Health Sciences Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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