A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
NCT06719141 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2026-05-18
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.
Conditions
- Developmental and Epileptic Encephalopathy
Interventions
- DRUG
-
LP352
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube
- DRUG
-
Participants will be administered with matching placebo orally or through G-tube/ PEG tube.
Sponsors & Collaborators
-
Longboard Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-11
- Primary Completion
- 2026-10-31
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Brazil
- Canada
- China
- France
- Germany
- Italy
- Japan
- Latvia
- Netherlands
- Portugal
- Serbia
- Spain
- United Kingdom
Study Locations
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