Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy

Last updated: January 23, 2025
Sponsor: Longboard Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Epilepsy

Dravet Syndrome

Seizure Disorders (Pediatric)

Treatment

LP352, bexicaserin

LP352

Clinical Study ID

NCT05626634
LP352-202
  • Ages 12-65
  • All Genders

Study Summary

The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating female, age 12 to 65 years who havesatisfactorily completed study LP352-201

  2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental andepileptic encephalopathy

  3. The patient/parent/caregiver is able and willing to attend study visits, completethe diary and take study drug as instructed

Exclusion

Exclusion Criteria:

  1. Had an SAE in Study LP352-201 that was definitely, probably, or possibly related toexposure to study drug

  2. Current or past history of cardiovascular or cerebrovascular disease, such ascardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertensionor abnormal blood pressure

  3. Has glaucoma, renal impairment, liver disease or any other medical condition thatwould affect study participation or pose a risk to the subject

  4. Current or recent history of moderate or severe depression, anorexia nervosa,bulimia or at risk of suicidal behavior

  5. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonistsor antagonists including fenfluramine, atomoxetine, vortioxetine, or othermedications for weight loss

  6. Positive test result on the drug screen, except tetrahydrocannabinol (THC) forpatients taking prescribed cannabidiol

Study Design

Total Participants: 41
Treatment Group(s): 2
Primary Treatment: LP352, bexicaserin
Phase: 2
Study Start date:
November 08, 2022
Estimated Completion Date:
December 20, 2024

Study Description

This Phase 2, multicenter, open-label, multiple-dose extension clinical study is designed to evaluate long-term safety of LP352 in subjects with developmental and epileptic encephalopathy who completed Study LP352-201.

The study consists of a Screening Period (Day -1) and a 50-week open-label Treatment Period that includes a 15-day Up-titration Period (during which time subjects will titrate up to their highest tolerated doses) and an open-label Maintenance Period (48 weeks). The Treatment Period will be followed by a Down-titration/Taper Period (up to 15 days) and Follow-up Period (14 days after completion of down-titration). The starting dose of up-titration will be 6 mg TID. The target final maintenance doses are 6 mg TID, 9 mg TID, and 12 mg TID after a 15-day up-titration period, if tolerated.

Connect with a study center

  • Queensland Children's Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Alfred Health

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Rancho Los Amigos National Rehabilitation Center (RLANRC)

    Downey, California 90242
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • Northwest Florida Clinical Research Group

    Gulf Breeze, Florida 32561
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Advent Health Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Research Institute of Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Boston Children's Health Physicians LLP

    Hawthorne, New York 10532
    United States

    Site Not Available

  • Northwell Health

    New York, New York 10075
    United States

    Site Not Available

  • Northeast Regional Epilepsy Group

    Staten Island, New York 10305
    United States

    Site Not Available

  • OnSite Clinical Solutions LLC

    Charlotte, North Carolina 98277
    United States

    Site Not Available

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Providence Neurological Specialties-East

    Portland, Oregon 97213
    United States

    Site Not Available

  • Austin Epilepsy Care Center

    Austin, Texas 78758
    United States

    Site Not Available

  • Child Neurology Consultants of Austin

    Austin, Texas 78757
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Washington Valley Medical Center

    Renton, Washington 98055
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.