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Dravet syndrome drug trial halted early: did lorcaserin help?

NCT ID NCT04572243

Disease control Sponsor: Eisai Inc. Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 · Last updated Jun 27, 2026

Summary

This study tested whether lorcaserin, when added to current medications, could reduce convulsive seizures in people with Dravet syndrome, a severe form of epilepsy. The trial planned to enroll about 22 participants aged 2 and older, but it was terminated early. The main goal was to measure the change in seizure frequency over 28 days compared to a placebo.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

22 people

The number who actually took part.

Started

Sep 2020

Finished

Aug 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

2 years and older

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.

Key Inclusion Criteria: Participants must meet all of the following criteria to be included in this study: 1. Male or female, age 2 years and older at the time of informed consent 2. Diagnosis of epilepsy with Dravet syndrome 3. Has at least 4 convulsive seizures during the 4 weeks of baseline 4. Current treatment with antiepileptic drugs must be stable for at least 4 weeks before screening, and be expected to remain stable throughout the study Key Exclusion Criteria: Participants who meet any of the following criteria will be excluded from this study: 1. Use of lorcaserin within 4 weeks before screening, or any history of it being discontinued due to lack of efficacy or adverse reactions 2. Use of fenfluramine within 2 months before screening, any history of lack of fenfluramine efficacy, or any history of valvulopathy at baseline with history of fenfluramine use 3. Recent or concomitant use of serotonergic medications or monoamine oxidase inhibitors 4. Presence of progressive central nervous system disease other than Dravet syndrome

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic epilepsy myoclonic epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsies, myoclonic

Contacts and locations

Locations

  • Alberta Children's Hospital

    Calgary, Alberta, AB T3B 6A8, Canada

  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3N1, Canada

  • Children's Hospital - VH, London Health Sciences Centre

    London, Ontario, N6A 4G5, Canada

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's of Alabama / University of Alabama at Birmingham

    Birmingham, Alabama, 35226, United States

  • Duke University Hospital Center

    Durham, North Carolina, 27710, United States

  • Institute of Neurology and Neurosurgery at Saint Barnabas

    Livingston, New Jersey, 07039, United States

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021, United States

  • Miami Children's Hospital - Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • Mid-Atlantic Epilepsy and Sleep Center - Bethesda

    Bethesda, Maryland, 20817, United States

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405, United States

  • NYU Langone Comprehensive Epilepsy Center

    New York, New York, 10016, United States

  • New York Medical College

    New York, New York, 10019-1147, United States

  • NorthWell Health - Lennox Hill Hospital

    New York, New York, 11021, United States

  • Northwell Health - Neuroscience Institute at Great Neck

    New Hyde Park, New York, 10075, United States

  • Northwest Florida Clinical Research Group

    Gulf Breeze, Florida, 32561, United States

  • Pediatric Neurology, P.A.

    Winter Park, Florida, 32789, United States

  • Rare Disease Research Center Pediatrics, LLC

    Atlanta, Georgia, 30318, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Spectrum Health/ Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503, United States

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 1C9, Canada

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • UCSD Rady's Children's Hosptial

    San Diego, California, 92123, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095, United States

  • University of Missouri, Department of Child Health, Division of Neurology

    Columbia, Missouri, 65201, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7025, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Toronto Division of Hematology Oncology/The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

More trials for these conditions

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