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

Last updated: January 28, 2025
Sponsor: Eisai Inc.
Overall Status: Planned

Phase

N/A

Condition

Unverricht-lundborg Syndrome

Epilepsy

Treatment

Lorcaserin

Clinical Study ID

NCT04457687
E2023-A001-405
  • Ages > 2
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of Dravet syndrome (according to Recommendation from a NorthAmerican Consensus Panel, 2017) or other refractory epilepsy (per the judgment ofthe 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 orother refractory epilepsies, and the treatment was initiated before 13 Feb 2020; orhas completed Study E2023-A001-304

  4. Has a clinical benefit from lorcaserin in the opinion of the treating physician

Exclusion

Exclusion Criteria:

None

Study Design

Treatment Group(s): 1
Primary Treatment: Lorcaserin
Phase:
Study Start date:
Estimated Completion Date:

Connect with a study center

  • Alberta Children's Hospita

    Calgary, Alberta T3B 6A8
    Canada

    Planned

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 1C9
    Canada

    Planned

  • BC Children's Hospital

    Vancouver, British Columbia V6H 3N1
    Canada

    Planned

  • Children's Hospital - VH, London Health Sciences Centre

    London, Ontario N6A 4G5
    Canada

    Planned

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Planned

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

    Los Angeles, California 90095
    United States

    Planned

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Planned

  • Pena

    Avon, Connecticut 06001
    United States

    Planned

  • (Resor)

    Greenwich, Connecticut 06830
    United States

    Planned

  • Children's National Medical Center

    Washington, District of Columbia 20019
    United States

    Planned

  • Clinical Neurosciences of Tampa Bay

    Clearwater, Florida 33764
    United States

    Planned

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

    Miami, Florida 33155
    United States

    Planned

  • Mid-Atlantic Epilepsy and Sleep Center - Bethesda

    Bethesda, Maryland 20817
    United States

    Planned

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Planned

  • Northeastern Regional Epilepsy Group (Hackensack)

    Hackensack, New Jersey 07601
    United States

    Planned

  • New York Medical College

    Hawthorne, New York 10532
    United States

    Planned

  • Mt. Sinai School of Medicine

    New York, New York 10029
    United States

    Planned

  • NYU Langone Comprehensive Epilepsy Center

    New York, New York 10016
    United States

    Planned

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Planned

  • Sidney Kimmel Medical College at Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Planned

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Planned

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Planned

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