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NCT06719141 · ClinicalTrials.gov registry record · Phase 3

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

A Phase 3 study of Developmental and Epileptic Encephalopathy, sponsored by Longboard Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
320
Enrollment target
20
Study locations

NCT06719141: Recruiting Phase 3 study of Developmental and Epileptic Encephalopathy, sponsored by Longboard Pharmaceuticals.

NCT06719141 is a Phase 3 study of Developmental and Epileptic Encephalopathy that is actively recruiting participants, run by Longboard Pharmaceuticals. The registered enrollment target is 320 participants, above the 48-participant average among 3 other Developmental and Epileptic Encephalopathy trials with a reported enrollment target (567% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06719141, a Phase 3 study of Developmental and Epileptic Encephalopathy, is actively recruiting participants, sponsored by Longboard Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
320 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.

Conditions Studied

Developmental and Epileptic Encephalopathy

Interventions

  • DRUG Placebo
  • DRUG LP352

Study Locations (20)

Florida

  • NW FL Clinical Research Group, LLC - Gulf Breeze
  • University of Miami - 1120 NW 14th St - Miami
  • Nicklaus Children's Hospital - PIN - Miami
  • Research Institute of Orlando LLC - Orlando
  • University of South Florida - 2 Tampa General Circle - Tampa
  • Pediatric Epilepsy and Neurology Specialists - Tampa

California

  • Children's Hospital Los Angeles - PIN - Los Angeles
  • David Geffen School of Medicine at UCLA - Los Angeles
  • The Stanford Division of Child Neurology - Palo Alto
  • UCSF Children's Hospital - San Francisco

Georgia

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics - PIN - Atlanta
  • Rare Disease Research, LLC - Atlanta - RDR - PIN - Atlanta

Arkansas

  • Arkansas Children's Hospital - PIN - Little Rock

Colorado

  • Children's Hospital Colorado. - Aurora

District of Columbia

  • Children's National Medical Center - Washington D.C.

Idaho

  • Consultants In Epilepsy and Neurology PLLC - Boise

Illinois

  • Ann and Robert H Lurie Childrens Hospital of Chicago - PIN - Chicago

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2024-11-11
Est. Completion 2026-11-30
Phase Phase 3
Longboard Pharmaceuticals

4 total trials

What NCT06719141 shows while recruiting

NCT06719141 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 48-participant average among 3 other Developmental and Epileptic Encephalopathy trials with a reported enrollment target (567% higher).

The record links to 1 condition, with Developmental and Epileptic Encephalopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06719141 names 20 study sites across 11 states, led by Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT06719141 about?

NCT06719141 is a clinical study titled "A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)". 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 peri...

What is the current status of trial NCT06719141?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2024-11-11. Estimated completion is 2026-11-30.

What conditions does trial NCT06719141 study?

This clinical trial studies the following conditions: Developmental and Epileptic Encephalopathy.

What interventions are being tested in trial NCT06719141?

The interventions under investigation include: Placebo (DRUG), LP352 (DRUG).

Who is sponsoring clinical trial NCT06719141?

This trial is sponsored by Longboard Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06719141 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06719141

Source: ClinicalTrials.gov NCT06719141, the US trial registry maintained by the National Library of Medicine. NCT06719141 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.