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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: Longboard Pharmaceuticals

NCT ID: NCT06660394

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 27 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
96
Started
2024-09-25
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for dravet syndrome
  • • Phase3 - 96 participants
  • • 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

Who can take part?

  • • Ages 2 Years to 65 Years
  • • Diagnosed with dravet syndrome

Where?

  • • Newcastle upon Tyne - The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
  • • Glasgow - NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...
  • • London - University College London Hospitals NHS Foundation Trust (UCLH)
  • • London - Great Ormond Street Hospital for Children NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Dravet Syndrome

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

  • ✓Diagnosis of DS must fulfill all of the following criteria:
  • ✓Participants with seizure onset age \>1 and \<20 months
  • ✓The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior...
  • ✓The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to...
  • ✓The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with...

Who cannot take part

  • ✗The participant has a history of infantile/epileptic spasms.
  • ✗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: * Diagnosis of DS must fulfill all of the following criteria: 1. Participants with seizure onset age \>1 and \<20 months 2. 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 * 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 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. Exclusion Criteria: * The participant has a history of infantile/epileptic spasms. * 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 unwilling to comply with any of the study requirements or timelines.

Where Is This Study? (4 UK sites)

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

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 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