Intermediate-Size Expanded Access Protocol (EAP) for LP352

January 20, 2025 updated by: Longboard Pharmaceuticals

Expanded Access Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)

This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. The EAP study will allow continued treatment with LP352 for eligible participants diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation) or an immediate family member who has the exact same gene mutation resulting in the same DEE epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin EAP.

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

  • Australia
      • Melbourne, Australia, 3004
        • Available
        • Alfred Hospital
    • Melbourne
      • Heidelberg, Melbourne, Australia, 3084
        • Available
        • Austin Hospital, Heidelberg
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Available
        • Children's Health Queensland Hospital and Health Service,
  • United States
    • California
      • Downey, California, United States, 90242
        • Available
        • Rancho Research Institute
      • Los Angeles, California, United States, 90095
        • Available
        • University of California Los Angeles (UCLA)
      • San Francisco, California, United States, 94609
        • Available
        • University of California Benioff Childrens Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Available
        • Colorados Childrens Hospital
    • Florida
      • Gulf Breeze, Florida, United States, 32502
        • Available
        • Northwest Florida Clinical Research Group
      • Orlando, Florida, United States, 32792
        • Available
        • Research Institute of Orlando
      • Tampa, Florida, United States, 33620
        • Available
        • University of Southern Florida
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Available
        • Hawaii Pacific Neuroscience
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Available
        • Northwestern Medicine Feinberg School of Medicine
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Available
        • Mid-Atlantic Epilepsy and Sleep Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49506
        • Available
        • Corewell Health
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Available
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10012
        • Available
        • New York University (NYU)
      • New York, New York, United States, 10075
        • Available
        • Lenox Hill Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Available
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97225
        • Available
        • Providence Brain & Spine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Available
        • Thomas Jefferson University
    • Texas
      • Austin, Texas, United States, 78757
        • Available
        • Children's Neuro Consultants of Austin
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Available
        • University of Utah

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. Participant and/or participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (<18 years of age) as required by local regulations.
  2. Participant with DEE who has successfully completed an LP352 Clinical Trial.
  3. Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
  4. Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.

Exclusion Criteria:

  1. Participant was discontinued from an LP352 Clinical Trial for any reason.
  2. Any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.

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

Longboard Pharmaceuticals

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

November 19, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP352-EAP-01

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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