Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies (NCT05364021) | Clinical Trial Compass
CompletedPhase 1/2
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
United States, Australia52 participantsStarted 2022-03-03
Plain-language summary
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 participate
Age range
12 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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