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NCT05626634
Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
Conditions: Developmental and Epileptic Encephalopathy, Dravet Syndrome, Lennox-Gastaut Syndrome
Sex: All
Ages: 12 Years – 65 Years
Phase: PHASE2
Enrollment: 50
Sponsor: Longboard Pharmaceuticals
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathyThe patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructedExclusion Criteria:Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drugCurrent or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressureHas glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subjectCurrent or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behaviorCurrently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight lossPositive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol
Source: ClinicalTrials.gov (NCT05626634). StuddyBuddy aggregates publicly available trial information.