At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LP352 (drug), Placebo (drug)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- LP352 — drug: LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube · Placebo — drug: Participants will be administered with matching placebo orally or through G-tube/ PEG tube.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 2 Years to 65 Years
- Who
- All
- Number of participants
- 367
- Started
- 2024-11-11
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for developmental and epileptic encephalopathy
- • Phase3 - 367 participants
- • 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
Who can take part?
- • Ages 2 Years to 65 Years
- • Diagnosed with developmental and epileptic encephalopathy
Where?
- • Cardiff - Cardiff and Vale University Health Board - University Hospital of Wales (UHW) - Noah's Ark Childr...
- • Newcastle upon Tyne - The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
- • Southampton - University Hospital Southampton NHS Foundation Trust-Southampton General Hospital (SGH)
- • Glasgow - NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years - 65 Years
- Who can join: All genders
What the study is looking for
- ✓Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria:
- ✓Onset of seizures at ≤8 years old
- ✓Presence of developmental plateauing or regression
- ✓History of electroencephalogram (EEG) showing generalized slow (\<2.5 Hertz \[Hz\]) spike-and-wave complexes
- ✓Participants who are characterized as having DEE (Other) must fulfill all of the following criteria:
Who cannot take part
- ✗The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1...
- ✗The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical...
- ✗The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.
- ✗The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary...
- ✗The participant is receiving exclusionary medications.
See the full criteria
Where Is This Study? (7 UK sites)
Cardiff and Vale University Health Board - University Hospital of Wales (UHW) - Noah's Ark Childr...
Cardiff CF14 4XW, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
Newcastle upon Tyne NE1 4LP, United Kingdom
University Hospital Southampton NHS Foundation Trust-Southampton General Hospital (SGH)
Southampton SO16 6YD, United Kingdom
NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...
Glasgow G51 4TF, United Kingdom
University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
Birmingham B15 2WB, United Kingdom
University College London Hospitals NHS Foundation Trust (UCLH)
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Great Ormond Street Hospital for Children NHS Foundation Trust
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700