Intermediate-Size Expanded Access Protocol (EAP) for LP352

Available (expanded access)

Conditions studied: Dravet Syndrome, Lennox Gastaut Syndrome, Developmental and Epileptic Encephalopathies

In brief

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.

Key facts

Study ID

NCT06149663

Run by

Longboard Pharmaceuticals

Last updated by the study team

2025-01-22

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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 — St 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
• Alfred Hospital — Melbourne, Melbourne, Australia
• Children's Health Queensland Hospital and Health Service, — South Brisbane, Queensland, Australia

Full record on ClinicalTrials.gov

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