The objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental and epileptic encephalopathies.
This is a randomized, double-blind, parallel-group, dose-escalation, placebo-controlled study of LP352 in adults and adolescents with developmental and epileptic encephalopathies (DEE) with an average of ≥ 4 observed/countable motor seizures per 4-week period during the 12 weeks before screening while on stable antiseizure medicine (ASM). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Treatment-emergent Adverse Events
Incidence and severity of 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 Day 75
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 Day 75
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 Day 75
Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Treatment Period
Time frame: Baseline up to Day 75
Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Maintenance Period
Time frame: Baseline up to Day 75
Observed Plasma Concentrations of LP352 by Time and Dose
Time frame: Baseline up to Day 75
Modeled Estimate of Average Plasma Concentration
Time frame: Baseline up to Day 75
Modeled Estimate of Observed Plasma Concentration Just Prior to Dosing
Time frame: Baseline up to Day 75
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 24 more locations
Correlation of Plasma Concentration with Incidence of Treatment-emergent Adverse Events
Time frame: Baseline up to Day 75
Correlation of Plasma Concentration with Seizure Frequency
Time frame: Baseline up to Day 75
Observed and Change from Baseline Prolactin Concentration During the Treatment Period
Time frame: Baseline up to Day 75