Intermediate-Size Expanded Access Protocol (EAP) for LP352

NCT ID: NCT06149663

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Dravet Syndrome Lennox Gastaut Syndrome Developmental and Epileptic Encephalopathies

Interventions

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LP352

LP352 will be administered as a liquid either orally or through a G-tube or Percutaneous Endoscopic Gastrotomy (PEG) tube.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Longboard Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rancho Research Institute

Downey, California, United States

Site Status AVAILABLE

University of California Los Angeles (UCLA)

Los Angeles, California, United States

Site Status AVAILABLE

University of California Benioff Childrens Hospital

San Francisco, California, United States

Site Status AVAILABLE

Colorados Childrens Hospital

Aurora, Colorado, United States

Site Status AVAILABLE

Northwest Florida Clinical Research Group

Gulf Breeze, Florida, United States

Site Status AVAILABLE

Research Institute of Orlando

Orlando, Florida, United States

Site Status AVAILABLE

University of Southern Florida

Tampa, Florida, United States

Site Status AVAILABLE

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Site Status AVAILABLE

Northwestern Medicine Feinberg School of Medicine

Chicago, Illinois, United States

Site Status AVAILABLE

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Site Status AVAILABLE

Corewell Health

Grand Rapids, Michigan, United States

Site Status AVAILABLE

Washington University School of Medicine

St Louis, Missouri, United States

Site Status AVAILABLE

New York University (NYU)

New York, New York, United States

Site Status AVAILABLE

Lenox Hill Hospital

New York, New York, United States

Site Status AVAILABLE

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status AVAILABLE

Providence Brain & Spine

Portland, Oregon, United States

Site Status AVAILABLE

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status AVAILABLE

Children's Neuro Consultants of Austin

Austin, Texas, United States

Site Status AVAILABLE

University of Utah

Salt Lake City, Utah, United States

Site Status AVAILABLE

Austin Hospital, Heidelberg

Heidelberg, Melbourne, Australia

Site Status AVAILABLE

Alfred Hospital

Melbourne, Melbourne, Australia

Site Status AVAILABLE

Children's Health Queensland Hospital and Health Service,

South Brisbane, Queensland, Australia

Site Status AVAILABLE

Countries

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United States Australia

Central Contacts

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Longboard Study Contact

Role: CONTACT

858-999-8858

Other Identifiers

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LP352-EAP-01

Identifier Type: -

Identifier Source: org_study_id

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