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 5343858, California 5332921, United States
University of California Los Angeles (UCLA)
Los Angeles 5368361, California 5332921, United States
University of California Benioff Childrens Hospital
San Francisco 5391959, California 5332921, United States
Colorados Childrens Hospital
Aurora 5412347, Colorado 5417618, United States
Northwest Florida Clinical Research Group
Gulf Breeze 4157634, Florida 4155751, United States
Research Institute of Orlando
Orlando 4167147, Florida 4155751, United States
University of Southern Florida
Tampa 4174757, Florida 4155751, United States
Hawaii Pacific Neuroscience
Honolulu 5856195, Hawaii 5855797, United States
Northwestern Medicine Feinberg School of Medicine
Chicago 4887398, Illinois 4896861, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda 4348599, Maryland 4361885, United States
Corewell Health
Grand Rapids 4994358, Michigan 5001836, United States
Washington University School of Medicine
St Louis 4407066, Missouri 4398678, United States
New York University (NYU)
New York 5128581, New York 5128638, United States
Lenox Hill Hospital
New York 5128581, New York 5128638, United States
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418, United States
Providence Brain & Spine
Portland 5746545, Oregon 5744337, United States
Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927, United States
Children's Neuro Consultants of Austin
Austin 4671654, Texas 4736286, United States
University of Utah
Salt Lake City 5780993, Utah 5549030, United States
Austin Hospital, Heidelberg
Heidelberg 2163654, Melbourne, Australia
Alfred Hospital
Melbourne 2158177, Melbourne, Australia
Children's Health Queensland Hospital and Health Service,
South Brisbane 2207259, Queensland 2152274, Australia
Longboard Study Contact
858-999-8858
clinicalstudies@longboardpharma.com
Not Provided