For Healthcare Professionals

Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies

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About the study

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.
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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

Key Inclusion Criteria:


  1. Male or non-pregnant, non-lactating female, age 12 to 65 years
  2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
  3. Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications
  4. All medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study
  5. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure
  2. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
  3. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
  4. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
  5. 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.

Study’s details


Contition

Developmental and Epileptic Encephalopathy,Dravet Syndrome,Lennox Gastaut Syndrome

Age (in years)

12 - 65

Phase

Phase 1/Phase 2

Participants needed

50

Est. Completion Date

Oct 31, 2023

Treatment type

Interventional


Sponsor

Longboard Pharmaceuticals

ClinicalTrials.gov identifier

NCT05364021

Study number

LP352-201

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