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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 2 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Expanded Access

Recruiting Locations

Rancho Research Institute
Downey, California 90242

University of California Los Angeles (UCLA)
Los Angeles, California 90095

University of California Benioff Childrens Hospital
San Francisco, California 94609

Colorados Childrens Hospital
Aurora, Colorado 80045

Northwest Florida Clinical Research Group
Gulf Breeze, Florida 32502

Research Institute of Orlando
Orlando, Florida 32792

University of Southern Florida
Tampa, Florida 33620

Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817

Northwestern Medicine Feinberg School of Medicine
Chicago, Illinois 60611

Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817

Corewell Health
Grand Rapids, Michigan 49506

Washington University School of Medicine
St Louis, Missouri 63110

New York University (NYU)
New York, New York 10012

Lenox Hill Hospital
New York, New York 10075

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Providence Brain & Spine
Portland, Oregon 97225

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Children's Neuro Consultants of Austin
Austin, Texas 78757

University of Utah
Salt Lake City, Utah 84132

More Details

Status
Available
Sponsor
Longboard Pharmaceuticals

Study Contact

Longboard Study Contact
858-999-8858
clinicalstudies@longboardpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.