A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
NCT ID: NCT04572243
Last Updated: 2025-10-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
22 participants
INTERVENTIONAL
2020-09-23
2024-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Seizure Therapy With Intravenous Levetiracetam and Lorazepam
NCT00465244
Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization
NCT01392768
Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
NCT01458522
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
NCT00175890
Effect of Levetiracetam on Brain Excitability
NCT00006191
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lorcaserin (Core Study and Open-label Extension Phase)
Participants will be randomized to receive lorcaserin administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to less than (\<) 20, 20 to \<40, and greater than or equal to (\>=) 40 kilogram (kg) will be 5, 10, and 20 milligram per day (mg/day) respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to \<20, 20 to \<40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.
Lorcaserin
Lorcaserin oral tablet, administered as oral suspension.
Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)
Participants will be randomized to receive lorcaserin matching placebo administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to \<20, 20 to \<40, and \>=40 kg will be 5, 10, and 20 mg/day respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to \<20, 20 to \<40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.
Placebo
Placebo matching to lorcaserin oral tablet, administered as oral suspension.
Lorcaserin
Lorcaserin oral tablet, administered as oral suspension.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Placebo matching to lorcaserin oral tablet, administered as oral suspension.
Lorcaserin
Lorcaserin oral tablet, administered as oral suspension.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
2 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's of Alabama / University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
UCSD Rady's Children's Hosptial
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Miami Children's Hospital - Nicklaus Children's Hospital
Miami, Florida, United States
Pediatric Neurology, P.A.
Winter Park, Florida, United States
Rare Disease Research Center Pediatrics, LLC
Atlanta, Georgia, United States
Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Bethesda, Maryland, United States
Spectrum Health/ Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
University of Missouri, Department of Child Health, Division of Neurology
Columbia, Missouri, United States
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston, New Jersey, United States
Northwell Health - Neuroscience Institute at Great Neck
New Hyde Park, New York, United States
NYU Langone Comprehensive Epilepsy Center
New York, New York, United States
New York Medical College
New York, New York, United States
NorthWell Health - Lennox Hill Hospital
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Hospital Center
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Children's Hospital - VH, London Health Sciences Centre
London, Ontario, Canada
University of Toronto Division of Hematology Oncology/The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E2023-A001-304
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.