New epilepsy drug shows promise in long-term safety trial

NCT ID NCT05626634

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Developmental and epileptic encephalopathy are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • Advent Health Orlando

    Orlando, Florida, 32803, United States

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Austin Epilepsy Care Center

    Austin, Texas, 78758, United States

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Boston Children's Health Physicians LLP

    Hawthorne, New York, 10532, United States

  • Child Neurology Consultants of Austin

    Austin, Texas, 78757, United States

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817, United States

  • Northeast Regional Epilepsy Group

    Staten Island, New York, 10305, United States

  • Northwell Health

    New York, New York, 10075, United States

  • Northwest Florida Clinical Research Group

    Gulf Breeze, Florida, 32561, United States

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • OnSite Clinical Solutions LLC

    Charlotte, North Carolina, 98277, United States

  • Providence Neurological Specialties-East

    Portland, Oregon, 97213, United States

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101, Australia

  • Rancho Los Amigos National Rehabilitation Center (RLANRC)

    Downey, California, 90242, United States

  • Research Institute of Orlando

    Orlando, Florida, 32806, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.