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 patients with Developmental and Epileptic Encephalopathies (DEEs). The EAP study will allow continued treatment with LP352 for eligible patients diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation).

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: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

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

Inclusion Criteria

1. Patient and/or patient'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. Patient with DEE who has successfully completed an LP352 Clinical Trial.
3. Patient currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
4. Patient currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.

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Exclusion Criteria

1. Patient 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.

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (3)

Mid-Atlantic Epilepsy and Sleep Center; 🇺🇸 Bethesda, Maryland, United States

Northwest Florida Clinical Research Group; 🇺🇸 Gulf Breeze, Florida, United States

Research Institute of Orlando; 🇺🇸 Orlando, Florida, United States