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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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

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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.
Phone iconCall 858-999-8858Email iconEmail Study Center

Study Details


Contition
Developmental and Epileptic Encephalopathy,Dravet Syndrome,Lennox-Gastaut Syndrome
Age (in years)
12 - 65
Phase
PHASE2
Participants Needed
41
Est. Completion Date
Dec 20, 2024
Treatment Type
INTERVENTIONAL

Sponsor
Longboard Pharmaceuticals
ClinicalTrials.gov NCT Identifier
NCT05626634
Study Number
LP352-202

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