Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy

Completed · Phase 2

Conditions studied: Developmental and Epileptic Encephalopathy, Dravet Syndrome, Lennox-Gastaut Syndrome

In brief

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.

Key facts

Study ID

NCT05626634

Run by

Longboard Pharmaceuticals

People needed

41

Starts

2022-11-08

Expected to finish

2024-12-20

Last updated by the study team

2025-12-03

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Rancho Los Amigos National Rehabilitation Center (RLANRC) — Downey, California, United States
• University of California San Francisco — San Francisco, California, United States
• Northwest Florida Clinical Research Group — Gulf Breeze, Florida, United States
• University of Miami — Miami, Florida, United States
• Advent Health Orlando — Orlando, Florida, United States
• Research Institute of Orlando — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Boston Children's Health Physicians LLP — Hawthorne, New York, United States
• Northwell Health — New York, New York, United States
• Northeast Regional Epilepsy Group — Staten Island, New York, United States
• OnSite Clinical Solutions LLC — Charlotte, North Carolina, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Providence Neurological Specialties-East — Portland, Oregon, United States
• Child Neurology Consultants of Austin — Austin, Texas, United States
• Austin Epilepsy Care Center — Austin, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Washington Valley Medical Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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