RecruitingPhase 3

A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

United States160 participantsStarted 2024-09-25

Plain-language 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.

Who can participate

Age range2 Years – 65 Years

SexALL

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Inclusion criteria

✓. Participants with seizure onset age \>1 and \<20 months
✓. 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

What they're measuring

Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline

Timeframe: Baseline and up to 15 Weeks

Trial details

NCT IDNCT06660394

SponsorLongboard Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-21

Contact for this trial

Email contact via H. Lundbeck A/S

+45 36301311 HQ_Medinfo@Lundbeck.com

View on ClinicalTrials.gov More Dravet Syndrome trials