This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
367
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.
Time frame: Baseline and up to 15 Weeks
Safety and Tolerability of LP352
Safety and tolerability as measured by incidence and severity of Treatment Emergent Adverse Events (TEAEs), Serious Adverse events (SAEs), AEs leading to discontinuation and clinically significant changes in laboratory parameters (hematology, serum chemistry and Urinalysis), physical examination findings, vital signs, growth parameters (height and weight), 12-lead electrocardiograms (ECGs), Columbia-Suicide Severity Rating Scale (C-SSRS) responses, and Patient Health Questionnaire-9 (PHQ-9) total score and Question 9 score.
Time frame: Up to 21 Weeks
Percentage of participants with ≥ 50% Reduction in countable motor seizures during the Treatment compared to Baseline
Time frame: Baseline and up to 15 Weeks
Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline
Time frame: Baseline and up to 15 Weeks
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