This study is not accepting new patients

Intermediate-Size Expanded Access Protocol (EAP) for LP352

a study on Dravet Syndrome Lennox-Gastaut Syndrome Developmental and Epileptic Encephalopathy Epileptic Encephalopathy Epilepsy CDKL5 Deficiency Disorder Tuberous Sclerosis

Summary

Eligibility
for people ages 2-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator
by Nilika Singhal

Description

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.

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)

Keywords

Dravet Syndrome, Lennox Gastaut Syndrome, Developmental and Epileptic Encephalopathies, CDKL5 deficiency disorder, developmental and epileptic encephalopathy, epilepsy, treatment resistant epilepsy, tuberous sclerosis complex, Myoclonic Epilepsies, Tuberous Sclerosis

Eligibility

You can join if…

Open to people ages 2-65

  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.

You CAN'T join if...

  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

  • University of California Benioff Childrens Hospital not accepting new patients
    San Francisco California 94609 United States
  • Rancho Research Institute not accepting new patients
    Downey California 90242 United States

Lead Scientist at UCSF

  • Nilika Singhal
    Nilika Singhal, MD is Associate Professor of Neurology at the University of California, San Francisco (UCSF). She specializes in the treatment of pediatric epilepsies, including early-life genetic epilepsies, surgical epilepsies, and focal epilepsies.

Details

Status
not accepting new patients
Start Date
Sponsor
Longboard Pharmaceuticals
ID
NCT06149663
Study Type
Expanded Access
Last Updated
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