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 Dravet Syndrome

Longboard Pharmaceuticals

Summary

This (DEEp SEA 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 DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. 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: * Diagnosis of DS must fulfill all of the following criteria: 1. Participants with seizure onset age \>1 and \<20 months 2. The participant has a history of at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus * The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, fo…

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 (97)

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