Status:
AVAILABLE
Intermediate-Size Expanded Access Protocol (EAP) for LP352
Lead Sponsor:
Longboard Pharmaceuticals
Conditions:
Dravet Syndrome
Lennox Gastaut Syndrome
Eligibility:
All Genders
2-65 years
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 wi...
Eligibility Criteria
Inclusion
- 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.
- Participant with DEE who has successfully completed an LP352 Clinical Trial.
- Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
- Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.
Exclusion
- Participant 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06149663
Last Update
January 22 2025
Active Locations (22)
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1
Rancho Research Institute
Downey, California, United States, 90242
2
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
3
University of California Benioff Childrens Hospital
San Francisco, California, United States, 94609
4
Colorados Childrens Hospital
Aurora, Colorado, United States, 80045