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Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 65 Years
Gender All
More Inclusion & Exclusion 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. 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05364021
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Longboard Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dennis J Dlugos, MD
Principal Investigator Affiliation Children's Hospital of Philadelphia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Developmental and Epileptic Encephalopathy, Dravet Syndrome, Lennox Gastaut Syndrome
Additional Details

This is a randomized, double-blind, parallel-group, dose-escalation, placebo-controlled study of LP352 in adults and adolescents with developmental and epileptic encephalopathies (DEE) with an average of ≥ 4 observed/countable motor seizures per 4-week period during the 12 weeks before screening while on stable antiseizure medicine (ASM). Subjects will be randomized 4:1 to LP352 or placebo. The study will have a baseline period of 28 days, followed by a 15 day up-titration period during which time subjects will titrate up to their highest tolerated doses, and a 60-day maintenance period. After Day 75, subjects will be tapered down over a period of up to 15 days, with a follow-up visit 30 days after last dose. Enrolled subjects will be allowed to continue treatment with up to 4 concomitant ASMs at a stable dose.

Arms & Interventions

Arms

Experimental: LP352

Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 60-day maintenance period and a 15-day taper/down titration period.

Placebo Comparator: Placebo

Placebo for LP352

Interventions

Drug: - LP352

LP352 administered three times daily, orally or through G-tube

Drug: - Placebo

Matching placebo for LP352 administered three times daily, orally or through G-tube

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tucson, Arizona

Status

Recruiting

Address

University of Arizona - Health Sciences Center

Tucson, Arizona, 85724

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Downey, California

Status

Recruiting

Address

Rancho Los Amigos National Rehabilitation Center (RLANRC)

Downey, California, 90242

Children's Hospital of Orange County, Orange, California

Status

Recruiting

Address

Children's Hospital of Orange County

Orange, California, 92868

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94158

Gulf Breeze, Florida

Status

Recruiting

Address

Northwest Florida Clinical Research Group

Gulf Breeze, Florida, 32561

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Advent Health Orlando, Orlando, Florida

Status

Recruiting

Address

Advent Health Orlando

Orlando, Florida, 32803

Research Institute of Orlando, Orlando, Florida

Status

Recruiting

Address

Research Institute of Orlando

Orlando, Florida, 32806

University of South Florida, Tampa, Florida

Status

Recruiting

Address

University of South Florida

Tampa, Florida, 33606

Hawaii Pacific Neuroscience, Honolulu, Hawaii

Status

Recruiting

Address

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817

Consultants in Epilepsy and Neurology, Boise, Idaho

Status

Recruiting

Address

Consultants in Epilepsy and Neurology

Boise, Idaho, 83702

Chicago, Illinois

Status

Recruiting

Address

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611

Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland

Status

Recruiting

Address

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817

Spectrum Health, Grand Rapids, Michigan

Status

Recruiting

Address

Spectrum Health

Grand Rapids, Michigan, 49503

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Boston Children's Health Physicians LLP, Hawthorne, New York

Status

Recruiting

Address

Boston Children's Health Physicians LLP

Hawthorne, New York, 10532

Mineola, New York

Status

Recruiting

Address

New York University Langone Hospital - Long Island

Mineola, New York, 11501

Northwell Health, New York, New York

Status

Recruiting

Address

Northwell Health

New York, New York, 10075

Northeast Regional Epilepsy Group, Staten Island, New York

Status

Recruiting

Address

Northeast Regional Epilepsy Group

Staten Island, New York, 10305

OnSite Clinical Solutions LLC, Charlotte, North Carolina

Status

Recruiting

Address

OnSite Clinical Solutions LLC

Charlotte, North Carolina, 98277

Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Providence Neurological Specialties-East, Portland, Oregon

Status

Recruiting

Address

Providence Neurological Specialties-East

Portland, Oregon, 97213

Child Neurology Consultants of Austin, Austin, Texas

Status

Recruiting

Address

Child Neurology Consultants of Austin

Austin, Texas, 78757

Austin Epilepsy Care Center, Austin, Texas

Status

Recruiting

Address

Austin Epilepsy Care Center

Austin, Texas, 78758

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84132

Renton, Washington

Status

Recruiting

Address

University of Washington Valley Medical Center

Renton, Washington, 98055

International Sites

Royal Brisbane Women's Hospital, Herston, Queensland, Australia

Status

Recruiting

Address

Royal Brisbane Women's Hospital

Herston, Queensland, 4029

Queensland Children's Hospital, South Brisbane, Queensland, Australia

Status

Recruiting

Address

Queensland Children's Hospital

South Brisbane, Queensland, 4101

Clayton, Victoria, Australia

Status

Recruiting

Address

Monash Children's Hospital, Monash Health

Clayton, Victoria, 3168

Austin Health, Heidelberg, Victoria, Australia

Status

Recruiting

Address

Austin Health

Heidelberg, Victoria, 3084

Alfred Health, Melbourne, Victoria, Australia

Status

Recruiting

Address

Alfred Health

Melbourne, Victoria, 3004

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