This is an intermediate-size expanded access program (EAP) study. The purpose of this EAPis to provide continued access to LP352, an investigational drug product beinginvestigated in participants with DEEs. The EAP study will allow continued treatment withLP352 for eligible participants diagnosed with treatment resistant DEEs who successfullycompleted an LP352 Clinical Trial (Enrollment by Invitation) or an immediate familymember who has the exact same gene mutation resulting in the same DEE epilepsy syndromephenotype or a patient who previously participated in the lorcaserin EAP.
Not Provided
Drug: LP352
LP352 will be administered as a liquid either orally or through a G-tube or Percutaneous
Endoscopic Gastrotomy (PEG) tube.
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.
Rancho Research Institute
Downey, California, 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
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, United States
Research Institute of Orlando
Orlando, Florida, United States
University of Southern Florida
Tampa, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Northwestern Medicine Feinberg School of Medicine
Chicago, Illinois, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Corewell Health
Grand Rapids, Michigan, United States
Washington University School of Medicine
Saint Louis, Missouri, United States
New York University (NYU)
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Providence Brain & Spine
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Children's Neuro Consultants of Austin
Austin, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Austin Hospital, Heidelberg
Heidelberg, Melbourne, Australia
Children's Health Queensland Hospital and Health Service,
South Brisbane, Queensland, Australia
Alfred Hospital
Melbourne, Australia
Longboard Study Contact
858-999-8858
clinicalstudies@longboardpharma.com
Not Provided