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NCT05364021CompletedPhase 1/2

Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies

Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-escalation Study to Investigate the Safety, Tolerability, PK, PD, and Exploratory Efficacy of LP352 in Subjects With Developmental and Epileptic Encephalopathies

Source: ClinicalTrials.gov · Last updated 8 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
52 (actual)
First submitted
22 Mar 2022
Start date
3 Mar 2022
Primary completion date
16 Nov 2023
Lead sponsor
Longboard Pharmaceuticals
Diseases
Epilepsy
NCT number
NCT05364021

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 52
  • From 3 Mar 2022 to the primary completion date, 16 Nov 2023
  • 34 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 12 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Monash Children's Hospital, Monash Health
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Austin Health
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Royal Brisbane & Women s Hospital
Coordinator of this site? Confirm its status
HerstonAustraliaUnknown status
Alfred Health
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Queensland Children's Hospital
Coordinator of this site? Confirm its status
South BrisbaneAustraliaUnknown status
Child Neurology Consultants of Austin
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Austin Epilepsy Care Center
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Mid-Atlantic Epilepsy and Sleep Center
Coordinator of this site? Confirm its status
BethesdaUnited StatesUnknown status
Consultants in Epilepsy and Neurology
Coordinator of this site? Confirm its status
BoiseUnited StatesUnknown status
Onsite Clinical Solutions, LLC
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Northwestern University Feinberg School of Medicine
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ChicagoUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
Rancho Los Amigos National Rehabilitation Center (RLANRC)
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DowneyUnited StatesUnknown status
Spectrum Health
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Grand RapidsUnited StatesUnknown status
Northwest Florida Clinical Research Group
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Gulf BreezeUnited StatesUnknown status
Boston Children's Health Physicians LLP
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HawthorneUnited StatesUnknown status
Hawaii Pacific Neuroscience
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HonoluluUnited StatesUnknown status
Arkansas Children's Hospital
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Little RockUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
New York University Langone Hospital - Long Island
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MineolaUnited StatesUnknown status
Northwell Health
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New YorkUnited StatesUnknown status
Children's Hospital of Orange County
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OrangeUnited StatesUnknown status
Advent Health Orlando
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OrlandoUnited StatesUnknown status
Research Institute of Orlando
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OrlandoUnited StatesUnknown status
Providence Neurological Specialties-East
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PortlandUnited StatesUnknown status
University of Washington Valley Medical Center
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RentonUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Northeast Regional Epilepsy Group
Coordinator of this site? Confirm its status
Staten IslandUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status
University of Arizona Health Sciences Center
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TucsonUnited StatesUnknown status
Wake Forest University School of Medicine
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.