Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Male or non-pregnant, non-lactating female, age 12 to 65 years
- Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
- Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications
- All medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study
- The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed
EXCLUSION CRITERIA
Key Exclusion Criteria:
- 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 1/Phase 2
Participants needed
50
Est. Completion Date
Oct 31, 2023
Treatment type
Interventional
Sponsor
Longboard Pharmaceuticals
ClinicalTrials.gov identifier
NCT05364021
Study number
LP352-201
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?