Intermediate-Size Expanded Access Protocol (EAP) for LP352
Expanded Access Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)
1 other identifier
expanded_access
N/A
2 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2023
CompletedFirst Posted
Study publicly available on registry
November 29, 2023
CompletedJanuary 22, 2025
February 1, 2024
November 19, 2023
January 20, 2025
Conditions
Keywords
Interventions
LP352 will be administered as a liquid either orally or through a G-tube or Percutaneous Endoscopic Gastrotomy (PEG) tube.
Eligibility Criteria
You may qualify if:
- 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.
- Participant with DEE who has successfully completed an LP352 Clinical Trial.
- Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
- Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.
You may not qualify if:
- Participant was discontinued from an LP352 Clinical Trial for any reason.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Rancho Research Institute
Downey, California, 90242, United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90095, United States
University of California Benioff Childrens Hospital
San Francisco, California, 94609, United States
Colorados Childrens Hospital
Aurora, Colorado, 80045, United States
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, 32502, United States
Research Institute of Orlando
Orlando, Florida, 32792, United States
University of Southern Florida
Tampa, Florida, 33620, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Northwestern Medicine Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
Corewell Health
Grand Rapids, Michigan, 49506, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
New York University (NYU)
New York, New York, 10012, United States
Lenox Hill Hospital
New York, New York, 10075, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Providence Brain & Spine
Portland, Oregon, 97225, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Children's Neuro Consultants of Austin
Austin, Texas, 78757, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Austin Hospital, Heidelberg
Heidelberg, Melbourne, 3084, Australia
Alfred Hospital
Melbourne, Melbourne, 3004, Australia
Children's Health Queensland Hospital and Health Service,
South Brisbane, Queensland, 4101, Australia