A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy

Longboard Pharmaceuticals

Summary

This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.

Eligibility

Age range: 2–66 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration. * Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302). * Participant has a body weight of ≥10 kg. * G-tubes/PEG tubes (if applicable) should be in stable and good working condition. Nasogastric tubes are not allowed except for short-term management. * Has at least one reliable and consistent par…

Locations (88)

Arkansas Children's Hospital - Cardiology Clinic
Little Rock, Arkansas
University of California Los Angeles (UCLA) - David Geffen School of Medicine - Global Health Pro...
Los Angeles, California
Stanford University - Stanford School of Medicine - Pulmonary and Cystic Fibrosis Center
Palo Alto, California
UCSF Benioff Children's Hospitals - San Francisco
San Francisco, California
Children's Hospital Colorado - Heart Institute
Aurora, Colorado
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida

Summary

Eligibility

Interventions

Locations (88)