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

January 28, 2025 updated by: Eisai Inc.

Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies

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

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Available
        • Alberta Children's Hospita
      • Edmonton, Alberta, Canada, T6G 1C9
        • Available
        • Stollery Children's Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Available
        • BC Children's Hospital
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Available
        • Children's Hospital - VH, London Health Sciences Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Available
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • Available
        • David Geffen School of Medicine, UCLA Mattel Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Available
        • Children's Hospital Colorado
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • Available
        • Pena
      • Greenwich, Connecticut, United States, 06830
        • Available
        • (Resor)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20019
        • Available
        • Children's National Medical Center
    • Florida
      • Clearwater, Florida, United States, 33764
        • Available
        • Clinical Neurosciences of Tampa Bay
      • Miami, Florida, United States, 33155
        • Available
        • Miami Children's Hospital - Nicklaus Children's Hospital Miami
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Available
        • Mid-Atlantic Epilepsy and Sleep Center - Bethesda
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Available
        • University of Missouri Health Care
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Available
        • Northeastern Regional Epilepsy Group (Hackensack)
    • New York
      • Hawthorne, New York, United States, 10532
        • Available
        • New York Medical College
      • New York, New York, United States, 10016
        • Available
        • NYU Langone Comprehensive Epilepsy Center
      • New York, New York, United States, 10029
        • Available
        • Mt. Sinai School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Available
        • University Hospital Cleveland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Available
        • Sidney Kimmel Medical College at Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15224
        • Available
        • Children's Hospital of Pittsburgh of UPMC
    • Texas
      • Houston, Texas, United States, 77030
        • Available
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2023-A001-405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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