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Intermediate-Size Expanded Access Protocol (EAP) for LP352

Expanded Access Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)

NCT06149663•Longboard Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 65 years

Sex

ALL

Healthy Volunteers

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.

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

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

Key Dates

Last Updated

January 22, 2025

Conditions

Dravet SyndromeLennox Gastaut SyndromeDevelopmental and Epileptic Encephalopathies

Interventions

LP352

DRUG

Contacts

Longboard Study Contact

CONTACT

858-999-8858 clinicalstudies@longboardpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intermediate-Size Expanded Access Protocol (EAP) for LP352

Inclusion Criteria

Exclusion Criteria

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Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age

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Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome