Intermediate-Size Expanded Access Protocol (EAP) for LP352
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
- Dravet Syndrome
- Lennox Gastaut Syndrome
- Developmental and Epileptic Encephalopathies
Eligibility
- Eligible Ages
- Between 2 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Downey, California 90242
University of California Los Angeles (UCLA)
Los Angeles, California 90095
Los Angeles, California 90095
University of California Benioff Childrens Hospital
San Francisco, California 94609
San Francisco, California 94609
Colorados Childrens Hospital
Aurora, Colorado 80045
Aurora, Colorado 80045
Northwest Florida Clinical Research Group
Gulf Breeze, Florida 32502
Gulf Breeze, Florida 32502
Research Institute of Orlando
Orlando, Florida 32792
Orlando, Florida 32792
University of Southern Florida
Tampa, Florida 33620
Tampa, Florida 33620
Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
Northwestern Medicine Feinberg School of Medicine
Chicago, Illinois 60611
Chicago, Illinois 60611
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817
Bethesda, Maryland 20817
Corewell Health
Grand Rapids, Michigan 49506
Grand Rapids, Michigan 49506
Washington University School of Medicine
St Louis, Missouri 63110
St Louis, Missouri 63110
New York University (NYU)
New York, New York 10012
New York, New York 10012
Lenox Hill Hospital
New York, New York 10075
New York, New York 10075
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Providence Brain & Spine
Portland, Oregon 97225
Portland, Oregon 97225
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Children's Neuro Consultants of Austin
Austin, Texas 78757
Austin, Texas 78757
University of Utah
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
More Details
- Status
- Available
- Sponsor
- Longboard Pharmaceuticals