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.
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
- ✓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
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
NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...
Glasgow G51 4TF, 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