Intermediate-Size Expanded Access Protocol (EAP) for LP352

Sponsor

Longboard Pharmaceuticals (Industry)

Overall Status

Available

CT.gov ID

NCT06149663

Collaborator

(none)

Location

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dravet Syndrome Lennox Gastaut Syndrome Developmental and Epileptic Encephalopathies	Drug: LP352

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

Patient 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.