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NCT06660394 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
A Phase 3 study of Dravet Syndrome, sponsored by Longboard Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT06660394: Recruiting Phase 3 study of Dravet Syndrome, sponsored by Longboard Pharmaceuticals.
NCT06660394 is a Phase 3 study of Dravet Syndrome that is actively recruiting participants, run by Longboard Pharmaceuticals. The registered enrollment target is 160 participants, above the 97-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06660394, a Phase 3 study of Dravet Syndrome, is actively recruiting participants, sponsored by Longboard Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LP352
Study Locations (20)
Florida
- NW FL Clinical Research Group, LLC - Gulf Breeze
- Nicklaus Children's Hospital - PIN - Miami
- Research Institute of Orlando LLC - Orlando
- Pediatric Epilepsy and Neurology Specialists - Tampa
California
- David Geffen School of Medicine at UCLA - Los Angeles
- The Stanford Division of Child Neurology - Palo Alto
- UCSF Children's Hospital - San Francisco
New Jersey
- Institute of Neurology and Neurosurgery at Saint Barnabas, LLC - Livingston
- Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave - Morristown
Texas
- Child Neurology Consultants of Austin - 6811 Austin Center Blvd - Austin
- Cook Children's Jane and John Justin Neurosciences Center - PIN - Fort Worth
Arkansas
- Arkansas Children's Hospital - PIN - Little Rock
Colorado
- Children's Hospital Colorado. - Aurora
Georgia
- Rare Disease Research, LLC - Atlanta - RDR - PIN - Atlanta
Illinois
- Ann and Robert H Lurie Childrens Hospital of Chicago - PIN - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2024-09-25 |
| Est. Completion | 2026-10-02 |
| Phase | Phase 3 |
What NCT06660394 shows while recruiting
NCT06660394 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 97-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (65% higher).
The record links to 1 condition, with Dravet Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06660394 names 20 study sites across 13 states, led by Florida, California, New Jersey.
Frequently Asked Questions
What is clinical trial NCT06660394 about?
NCT06660394 is a clinical study titled "A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)". 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 per...
What is the current status of trial NCT06660394?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2024-09-25. Estimated completion is 2026-10-02.
What conditions does trial NCT06660394 study?
This clinical trial studies the following conditions: Dravet Syndrome.
What interventions are being tested in trial NCT06660394?
The interventions under investigation include: Placebo (DRUG), LP352 (DRUG).
Who is sponsoring clinical trial NCT06660394?
This trial is sponsored by Longboard Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06660394 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06660394's enrollment target sits among peer trials
160 3rd of 12 higher than 10 of 12 other Dravet Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dravet Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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