Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
NCT ID: NCT05626634
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2022-11-08
2024-12-20
Brief Summary
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Detailed Description
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The study consists of a Screening Period (Day -1) and a 50-week open-label Treatment Period that includes a 15-day Up-titration Period (during which time subjects will titrate up to their highest tolerated doses) and an open-label Maintenance Period (48 weeks). The Treatment Period will be followed by a Down-titration/Taper Period (up to 15 days) and Follow-up Period (14 days after completion of down-titration). The starting dose of up-titration will be 6 mg TID. The target final maintenance doses are 6 mg TID, 9 mg TID, and 12 mg TID after a 15-day up-titration period, if tolerated.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LP352, bexicaserin
Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 48-week maintenance period and a 15-day taper/down titration period.
LP352, bexicaserin
LP352 6 mg, 9 mg or 12 mg administered three times daily, orally or through G-tube
Interventions
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LP352, bexicaserin
LP352 6 mg, 9 mg or 12 mg administered three times daily, orally or through G-tube
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
65 Years
ALL
No
Sponsors
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Longboard Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis J Dlugos, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Rancho Los Amigos National Rehabilitation Center (RLANRC)
Downey, California, United States
University of California San Francisco
San Francisco, California, United States
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, United States
University of Miami
Miami, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Research Institute of Orlando
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Spectrum Health
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Boston Children's Health Physicians LLP
Hawthorne, New York, United States
Northwell Health
New York, New York, United States
Northeast Regional Epilepsy Group
Staten Island, New York, United States
OnSite Clinical Solutions LLC
Charlotte, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Providence Neurological Specialties-East
Portland, Oregon, United States
Child Neurology Consultants of Austin
Austin, Texas, United States
Austin Epilepsy Care Center
Austin, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Washington Valley Medical Center
Renton, Washington, United States
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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LP352-202
Identifier Type: -
Identifier Source: org_study_id
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