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

CompletedPhase 2

Sponsor: Longboard Pharmaceuticals

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

Interventions: LP352, bexicaserin

Countries: United States, Australia

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201
2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
3. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed

Exclusion Criteria:

1. Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drug
2. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure
3. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
4. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
5. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
6. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol

Locations (28)

Little Rock, Arkansas, United States
Downey, California, United States
San Francisco, California, United States
Gulf Breeze, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Bethesda, Maryland, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Hawthorne, New York, United States
New York, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Austin, Texas, United States
Austin, Texas, United States
Salt Lake City, Utah, United States
Renton, Washington, United States
South Brisbane, Queensland, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia