Intermediate-Size Expanded Access Protocol (EAP) for LP352

• Conditions: Dravet Syndrome; Lennox Gastaut Syndrome; Developmental 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

Study Timeline

• Study First Submitted: 2023-11-19
• Study First Submitted QC: 2023-11-19
• Study First Posted: 2023-11-29
• Status Verified: 2024-02
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (22)

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

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

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

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