Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Developmental and Epileptic Encephalopathy,Dravet Syndrome,Lennox-Gastaut Syndrome
Age (in years)
12 - 65
Phase
Phase 2
Participants needed
50
Est. Completion Date
Oct 31, 2024
Treatment type
Interventional
Sponsor
Longboard Pharmaceuticals
ClinicalTrials.gov identifier
NCT05626634
Study number
LP352-202
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