New epilepsy drug shows promise in long-term safety trial
NCT ID NCT05626634
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested the long-term safety of a drug called LP352 (bexicaserin) in 41 people aged 12 to 65 with severe epilepsy syndromes like Dravet or Lennox-Gastaut. Participants took the drug three times daily for up to 52 weeks. The main goal was to check for side effects, while also tracking seizure changes. Results will help decide if larger, more definitive studies are warranted.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LP352 (bexicaserin)
- What this could lead to
- If successful, this could show that LP352 is safe enough to use long-term for controlling seizures in people with severe epilepsy syndromes.
- What could go wrong
- This is a small, early-phase study (41 people) focused on safety, not proof of effectiveness. Side effects or lack of seizure reduction could limit future use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
41 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
-
Dec 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201 2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy 3. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed Exclusion Criteria: 1. Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drug 2. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure 3. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject 4. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior 5. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss 6. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Advent Health Orlando
Orlando, Florida, 32803, United States
-
Alfred Health
Melbourne, Victoria, 3004, Australia
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Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
-
Austin Epilepsy Care Center
Austin, Texas, 78758, United States
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Austin Health
Heidelberg, Victoria, 3084, Australia
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Boston Children's Health Physicians LLP
Hawthorne, New York, 10532, United States
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Child Neurology Consultants of Austin
Austin, Texas, 78757, United States
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Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
-
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
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Northeast Regional Epilepsy Group
Staten Island, New York, 10305, United States
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Northwell Health
New York, New York, 10075, United States
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Northwest Florida Clinical Research Group
Gulf Breeze, Florida, 32561, United States
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
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OnSite Clinical Solutions LLC
Charlotte, North Carolina, 98277, United States
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Providence Neurological Specialties-East
Portland, Oregon, 97213, United States
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Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
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Rancho Los Amigos National Rehabilitation Center (RLANRC)
Downey, California, 90242, United States
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Research Institute of Orlando
Orlando, Florida, 32806, United States
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Spectrum Health
Grand Rapids, Michigan, 49503, United States
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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University of California San Francisco
San Francisco, California, 94158, United States
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University of Miami
Miami, Florida, 33136, United States
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University of South Florida
Tampa, Florida, 33606, United States
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University of Utah
Salt Lake City, Utah, 84132, United States
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University of Washington Valley Medical Center
Renton, Washington, 98055, United States
-
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
-
Washington University School of Medicine
St Louis, Missouri, 63110, United States
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