Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
NCT ID: NCT05364021
Last Updated: 2024-11-08
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
PHASE1/PHASE2
52 participants
INTERVENTIONAL
2022-03-03
2023-11-20
Brief Summary
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Detailed Description
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Subjects will be randomized 4:1 to LP352 or placebo. The study will have a baseline period of 28 days, followed by a 15 day up-titration period during which time subjects will titrate up to their highest tolerated doses, and a 60-day maintenance period. After Day 75, subjects will be tapered down over a period of up to 15 days, with a follow-up visit 30 days after last dose. Enrolled subjects will be allowed to continue treatment with up to 4 concomitant ASMs at a stable dose.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LP352
Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 60-day maintenance period and a 15-day taper/down titration period.
LP352
LP352 administered three times daily, orally or through G-tube
Placebo
Placebo for LP352
Placebo
Matching placebo for LP352 administered three times daily, orally or through G-tube
Interventions
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LP352
LP352 administered three times daily, orally or through G-tube
Placebo
Matching placebo for LP352 administered three times daily, orally or through G-tube
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
3. Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications
4. All medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study
5. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed
Exclusion Criteria
2. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
3. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
4. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
5. 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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University of Arizona - Health Sciences Center
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Rancho Los Amigos National Rehabilitation Center (RLANRC)
Downey, California, United States
Children's Hospital of Orange County
Orange, 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
Consultants in Epilepsy and Neurology
Boise, Idaho, 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
New York University Langone Hospital - Long Island
Mineola, 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
Royal Brisbane Women's Hospital
Herston, Queensland, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Monash Children's Hospital, Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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LP352-201
Identifier Type: -
Identifier Source: org_study_id
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