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NCT05626634 · ClinicalTrials.gov registry record · Phase 2
Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
A Phase 2 study of Dravet Syndrome and Lennox Gastaut Syndrome, sponsored by Longboard Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 20
- Study locations
NCT05626634: Completed Phase 2 study of Dravet Syndrome and Lennox Gastaut Syndrome, sponsored by Longboard Pharmaceuticals.
NCT05626634 is a Phase 2 study of Dravet Syndrome and Lennox Gastaut Syndrome that has completed, run by Longboard Pharmaceuticals. The registered enrollment target is 41 participants, below the 106-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05626634, a Phase 2 study of Dravet Syndrome and Lennox Gastaut Syndrome, has completed, sponsored by Longboard Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.
Primary Outcome
Incidence and severity of treatment-emergent adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs
Conditions Studied
Interventions
- DRUG LP352, bexicaserin
Study Locations (20)
Florida
- Northwest Florida Clinical Research Group - Gulf Breeze
- University of Miami - Miami
- Advent Health Orlando - Orlando
- Research Institute of Orlando - Orlando
- University of South Florida - Tampa
New York
- Boston Children's Health Physicians LLP - Hawthorne
- Northwell Health - New York
- Northeast Regional Epilepsy Group - Staten Island
California
- Rancho Los Amigos National Rehabilitation Center (RLANRC) - Downey
- University of California San Francisco - San Francisco
North Carolina
- OnSite Clinical Solutions LLC - Charlotte
- Wake Forest University School of Medicine - Winston-Salem
Arkansas
- Arkansas Children's Hospital - Little Rock
Hawaii
- Hawaii Pacific Neuroscience - Honolulu
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Maryland
- Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2024-12-20 |
| Phase | Phase 2 |
What the finished NCT05626634 record still lists
NCT05626634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 106-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (61% lower).
The record links to 3 conditions, with Dravet Syndrome appearing as the primary indexed condition, and to 1 intervention - of which LP352, bexicaserin is the first listed.
NCT05626634 names 20 study sites across 12 states, led by Florida, New York, California.
Frequently Asked Questions
What is clinical trial NCT05626634 about?
NCT05626634 is a clinical study titled "Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy". The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.
What is the current status of trial NCT05626634?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2022-11-08. Estimated completion is 2024-12-20.
What conditions does trial NCT05626634 study?
This clinical trial studies the following conditions: Dravet Syndrome, Lennox Gastaut Syndrome, Developmental and Epileptic Encephalopathy.
What interventions are being tested in trial NCT05626634?
The interventions under investigation include: LP352, bexicaserin (DRUG).
Who is sponsoring clinical trial NCT05626634?
This trial is sponsored by Longboard Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05626634 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05626634's enrollment target sits among peer trials
41 9th of 12 higher than 4 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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