A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathies

Longboard Pharmaceuticals

Summary

This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.

Eligibility

Age range: 2–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria: * Onset of seizures at ≤8 years old * History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms * Presence of developmental plateauing or regression * History of electroencephalogram (EEG) showing generalized slow (\<2.5 Hertz \[Hz\]) spike-and-wave complexes * Participants…

Interventions

Drug
LP352
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube
Drug
Placebo
Participants will be administered with matching placebo orally or through G-tube/ PEG tube.

Locations (109)

Arkansas Children's Hospital - PIN
Little Rock, Arkansas
Children's Hospital Los Angeles - PIN
Los Angeles, California
David Geffen School of Medicine at UCLA
Los Angeles, California
The Stanford Division of Child Neurology
Palo Alto, California
UCSF Children's Hospital
San Francisco, California
Children's Hospital Colorado.
Aurora, Colorado