A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome

Last updated: September 19, 2025
Sponsor: Eisai Inc.
Overall Status: Terminated

Phase

3

Condition

Epilepsy

Unverricht-lundborg Syndrome

Treatment

Lorcaserin

Placebo

Clinical Study ID

NCT04572243
E2023-A001-304
  • Ages > 2
  • All Genders

Study Summary

The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study:

  1. Male or female, age 2 years and older at the time of informed consent

  2. Diagnosis of epilepsy with Dravet syndrome

  3. Has at least 4 convulsive seizures during the 4 weeks of baseline

  4. Current treatment with antiepileptic drugs must be stable for at least 4 weeksbefore screening, and be expected to remain stable throughout the study

Exclusion

Key Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

  1. Use of lorcaserin within 4 weeks before screening, or any history of it beingdiscontinued due to lack of efficacy or adverse reactions

  2. Use of fenfluramine within 2 months before screening, any history of lack offenfluramine efficacy, or any history of valvulopathy at baseline with history offenfluramine use

  3. Recent or concomitant use of serotonergic medications or monoamine oxidaseinhibitors

  4. Presence of progressive central nervous system disease other than Dravet syndrome

Study Design

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: Lorcaserin
Phase: 3
Study Start date:
September 23, 2020
Estimated Completion Date:
August 15, 2024

Connect with a study center

  • Alberta Children's Hospital

    Calgary, Alberta AB T3B 6A8
    Canada

    Site Not Available

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 1C9
    Canada

    Site Not Available

  • Alberta Children's Hospital

    Calgary 5913490, Alberta 5883102 AB T3B 6A8
    Canada

    Site Not Available

  • Stollery Children's Hospital

    Edmonton 5946768, Alberta 5883102 T6G 1C9
    Canada

    Site Not Available

  • BC Children's Hospital

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

  • BC Children's Hospital

    Vancouver 6173331, British Columbia 5909050 V6H 3N1
    Canada

    Site Not Available

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

    London, Ontario N6A 4G5
    Canada

    Site Not Available

  • University of Toronto Division of Hematology Oncology/The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

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

    London 6058560, Ontario 6093943 N6A 4G5
    Canada

    Site Not Available

  • University of Toronto Division of Hematology Oncology/The Hospital for Sick Children

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Site Not Available

  • Children's of Alabama / University of Alabama at Birmingham

    Birmingham, Alabama 35226
    United States

    Site Not Available

  • Children's of Alabama / University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35226
    United States

    Site Not Available

  • University of California Los Angeles (UCLA)

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCSD Rady's Children's Hosptial

    San Diego, California 92123
    United States

    Site Not Available

  • University of California Los Angeles (UCLA)

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • UCSD Rady's Children's Hosptial

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Northwest Florida Clinical Research Group

    Gulf Breeze, Florida 32561
    United States

    Site Not Available

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

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

    Miami, Florida 33155
    United States

    Site Not Available

  • Pediatric Neurology, P.A.

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Northwest Florida Clinical Research Group

    Gulf Breeze 4157634, Florida 4155751 32561
    United States

    Site Not Available

  • Joe DiMaggio Children's Hospital

    Hollywood 4158928, Florida 4155751 33021
    United States

    Site Not Available

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

    Miami 4164138, Florida 4155751 33155
    United States

    Site Not Available

  • Pediatric Neurology, P.A.

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Rare Disease Research Center Pediatrics, LLC

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Rare Disease Research Center Pediatrics, LLC

    Atlanta 4180439, Georgia 4197000 30318
    United States

    Site Not Available

  • Mid-Atlantic Epilepsy and Sleep Center - Bethesda

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Mid-Atlantic Epilepsy and Sleep Center - Bethesda

    Bethesda 4348599, Maryland 4361885 20817
    United States

    Site Not Available

  • Spectrum Health/ Helen DeVos Children's Hospital

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Spectrum Health/ Helen DeVos Children's Hospital

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Site Not Available

  • University of Missouri, Department of Child Health, Division of Neurology

    Columbia, Missouri 65201
    United States

    Site Not Available

  • University of Missouri, Department of Child Health, Division of Neurology

    Columbia 4381982, Missouri 4398678 65201
    United States

    Site Not Available

  • Institute of Neurology and Neurosurgery at Saint Barnabas

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Institute of Neurology and Neurosurgery at Saint Barnabas

    Livingston 5100572, New Jersey 5101760 07039
    United States

    Site Not Available

  • Northwell Health - Neuroscience Institute at Great Neck

    New Hyde Park, New York 10075
    United States

    Site Not Available

  • NYU Langone Comprehensive Epilepsy Center

    New York, New York 10016
    United States

    Site Not Available

  • New York Medical College

    New York, New York 10019-1147
    United States

    Site Not Available

  • NorthWell Health - Lennox Hill Hospital

    New York, New York 11021
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Northwell Health - Neuroscience Institute at Great Neck

    New Hyde Park 5128514, New York 5128638 10075
    United States

    Site Not Available

  • NYU Langone Comprehensive Epilepsy Center

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • New York Medical College

    New York 5128581, New York 5128638 10019-1147
    United States

    Site Not Available

  • NorthWell Health - Lennox Hill Hospital

    New York 5128581, New York 5128638 11021
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14642
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599-7025
    United States

    Site Not Available

  • Duke University Hospital Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27599-7025
    United States

    Site Not Available

  • Duke University Hospital Center

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh 5206379, Pennsylvania 6254927 15224
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

  • MultiCare Institute for Research & Innovation

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

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