Status:
COMPLETED
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
Lead Sponsor:
Longboard Pharmaceuticals
Conditions:
Developmental and Epileptic Encephalopathy
Dravet Syndrome
Eligibility:
All Genders
12-65 years
Phase:
PHASE1
PHASE2
Brief 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 encephalopat...
Detailed Description
This is a randomized, double-blind, parallel-group, dose-escalation, placebo-controlled study of LP352 in adults and adolescents with developmental and epileptic encephalopathies (DEE) with an average...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05364021
Start Date
March 3 2022
End Date
November 20 2023
Last Update
November 8 2024
Active Locations (34)
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1
University of Arizona - Health Sciences Center
Tucson, Arizona, United States, 85724
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Rancho Los Amigos National Rehabilitation Center (RLANRC)
Downey, California, United States, 90242
4
Children's Hospital of Orange County
Orange, California, United States, 92868