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

Conditions
Epilepsies, Myoclonic
Drug 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
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

Study & Design

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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

(Resor)

🇺🇸

Greenwich, Connecticut, 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

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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States

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