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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: Longboard Pharmaceuticals

NCT ID: NCT06719141

View on ClinicalTrials.gov ↗

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.

Developmental and Epileptic Encephalopathy

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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
Inclusion Criteria: * Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria: * Onset of seizures at ≤8 years old * History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms * 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: * Does not meet criteria for LGS * Onset of seizures at ≤5 years old * Presence of developmental plateauing or regression * History of multiple seizure types * History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity) * 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, focal motor (including hemiclonic), and focal to bilateral tonic-clonic. * The participant has demonstrated an average of at least 4 countable motor seizures per month for each of the 3 months prior to Screening. * The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening. * The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study. * The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative. Exclusion Criteria: * The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS. * The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening. * 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 cause of seizures. * The participant is receiving exclusionary medications. * The participant is currently using any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC). * The participant has unstable, clinically significant neurologic (other than the disease being studied; eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results. * The participant is unable or unwilling to comply with any of the study requirements or timelines.

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

Hospital R&D contact (matched)

Sarah Martin

research.development@wales.nhs.uk029 2074 6986

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)

Newcastle upon Tyne NE1 4LP, United Kingdom

Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

University Hospital Southampton NHS Foundation Trust-Southampton General Hospital (SGH)

Southampton SO16 6YD, United Kingdom

Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...

Glasgow G51 4TF, United Kingdom

Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham

Birmingham B15 2WB, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

University College London Hospitals NHS Foundation Trust (UCLH)

London NW1 2PG, United Kingdom

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Great Ormond Street Hospital for Children NHS Foundation Trust

London WC1N 3JH, United Kingdom

Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700
Data sourced from ClinicalTrials.gov · Last verified: 2026-09