Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
- Conditions
- Lennox-Gastaut SyndromeDravet SyndromeDevelopmental and Epileptic Encephalopathy
- Interventions
- Drug: LP352, bexicaserin
- Registration Number
- NCT05626634
- Lead Sponsor
- Longboard Pharmaceuticals
- Brief Summary
The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.
- Detailed Description
This Phase 2, multicenter, open-label, multiple-dose extension clinical study is designed to evaluate long-term safety of LP352 in subjects with developmental and epileptic encephalopathy who completed Study LP352-201.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201
- Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
- The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed
- Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drug
- Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure
- Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
- Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
- Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
- Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LP352, bexicaserin 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.
- Primary Outcome Measures
Name Time Method Treatment-emergent Adverse Events Baseline up to Week 52 Incidence and severity of treatment-emergent adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs
Patient Health Questionnaire-9 Total Score and Question 9 Score Baseline up to Week 52 Severity Rating Scale: 0 - 27; higher scores indicate greater severity of depressive disorder
Columbia-Suicide Severity Rating Scale (C-SSRS) Response Baseline up to Week 52 Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Observed Countable Motor Seizure Frequency During the Treatment Period Baseline to Week 50 Baseline Used for Seizure Frequency = Baseline from Study LP352-201 and Baseline from Study LP352-202
Percent of Subjects with Countable Motor Seizure-free Days During the Treatment Period Baseline to Week 50 Proportion of Subjects with > 50% Reduction in Total Seizures During the Treatment Period Baseline to Week 50 Percent Reduction in Individual Seizure Type During the Treatment Period Baseline to Week 50 Proportion of Subjects Requiring Rescue Medication During the Treatment Period Baseline to Week 50 Percent Change from Baseline in the Number of Episodes of Status Epilepticus During the Treatment Period Baseline to Week 50 LGS: Percentage Change from Baseline in the Frequency of Observed Drop Seizures Over the Treatment Period Baseline to Week 50 Percentage Change from Baseline in Non-motor and Difficult to Count Seizures Baseline to Week 50
Trial Locations
- Locations (28)
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Northeast Regional Epilepsy Group
🇺🇸Staten Island, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Alfred Health
🇦🇺Melbourne, Victoria, Australia
Queensland Children's Hospital
🇦🇺South Brisbane, Queensland, Australia
University of South Florida
🇺🇸Tampa, Florida, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Providence Neurological Specialties-East
🇺🇸Portland, Oregon, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Northwest Florida Clinical Research Group
🇺🇸Gulf Breeze, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Northwell Health
🇺🇸New York, New York, 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
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Rancho Los Amigos National Rehabilitation Center (RLANRC)
🇺🇸Downey, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Boston Children's Health Physicians LLP
🇺🇸Hawthorne, New York, United States
OnSite Clinical Solutions LLC
🇺🇸Charlotte, North Carolina, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Research Institute of Orlando
🇺🇸Orlando, Florida, United States
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Child Neurology Consultants of Austin
🇺🇸Austin, Texas, United States