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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
LP352 6 mg, 9 mg or 12 mg administered three times daily, orally or through G-tube
Treatment-emergent Adverse Events
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
Time frame: Baseline up to Week 52
Columbia-Suicide Severity Rating Scale (C-SSRS) Response
Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior
Time frame: Baseline up to Week 52
Patient Health Questionnaire-9 Total Score and Question 9 Score
Severity Rating Scale: 0 - 27; higher scores indicate greater severity of depressive disorder
Time frame: Baseline up to Week 52
Percent Change from Baseline in Observed Countable Motor Seizure Frequency During the Treatment Period
Baseline Used for Seizure Frequency = Baseline from Study LP352-201 and Baseline from Study LP352-202
Time frame: Baseline to Week 50
Proportion of Subjects with > 50% Reduction in Total Seizures During the Treatment Period
Time frame: Baseline to Week 50
Percent Reduction in Individual Seizure Type During the Treatment Period
Time frame: Baseline to Week 50
Proportion of Subjects Requiring Rescue Medication During the Treatment Period
Time frame: Baseline to Week 50
Percent Change from Baseline in the Number of Episodes of Status Epilepticus During the Treatment Period
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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
...and 18 more locations
Time frame: Baseline to Week 50
Percent of Subjects with Countable Motor Seizure-free Days During the Treatment Period
Time frame: Baseline to Week 50
Percentage Change from Baseline in Non-motor and Difficult to Count Seizures
Time frame: Baseline to Week 50
LGS: Percentage Change from Baseline in the Frequency of Observed Drop Seizures Over the Treatment Period
Time frame: Baseline to Week 50