Intermediate-Size Expanded Access Protocol (EAP) for LP352
- Conditions
- Dravet SyndromeLennox Gastaut SyndromeDevelopmental and Epileptic Encephalopathies
- Registration Number
- NCT06149663
- Lead Sponsor
- Longboard Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Rancho Research Institute
🇺🇸Downey, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Children's Neuro Consultants of Austin
🇺🇸Austin, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of California Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
University of California Benioff Childrens Hospital
🇺🇸San Francisco, California, United States
Colorados Childrens Hospital
🇺🇸Aurora, Colorado, United States
University of Southern Florida
🇺🇸Tampa, Florida, United States
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Northwestern Medicine Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
New York University (NYU)
🇺🇸New York, New York, United States
Austin Hospital, Heidelberg
🇦🇺Heidelberg, Melbourne, Australia
Children's Health Queensland Hospital and Health Service,
🇦🇺South Brisbane, Queensland, Australia
Alfred Hospital
🇦🇺Melbourne, Australia
Research Institute of Orlando
🇺🇸Orlando, Florida, United States
Providence Brain & Spine
🇺🇸Portland, Oregon, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Northwest Florida Clinical Research Group
🇺🇸Gulf Breeze, Florida, United States
Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States