ENROLLING_BY_INVITATION

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.

Official Title

A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy

Quick Facts

Study Start:2025-02-12
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06908226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 66 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration.
  2. * Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).
  3. * Has at least one reliable and consistent parent, legal guardian, or caregiver during the study.
  4. * The participant or legal representative must be willing and able to provide written informed consent
  5. * The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.
  1. * The participant is receiving exclusionary medications.
  2. * Current use of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing ≥50% Delta-9-tetrahydrocannabinol (THC).
  3. * The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia) pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
  4. * The participant is unable or unwilling to comply with any of the study requirements or timelines.

Contacts and Locations

Study Locations (Sites)

Site Number - USA19
Little Rock, Arkansas, 72202
United States
Site Number - USA29
La Jolla, California, 92037
United States
Site Number - USA26
Los Angeles, California, 90027
United States
Site Number - USA18
Los Angeles, California, 90095
United States
Site Number - USA24
Palo Alto, California, 94304
United States
Site Number - USA28
San Francisco, California, 94904
United States
Site Number - USA17
Aurora, Colorado, 80045
United States
Site Number - USA02
Gulf Breeze, Florida, 32561
United States
Site Number - USA37
Miami, Florida, 33155
United States
Site Number - USA05
Orlando, Florida, 32806
United States
Site Number - USA11
Tampa, Florida, 33609
United States
Site Number - USA09
Atlanta, Georgia, 30329
United States
Site Number - USA38
Chicago, Illinois, 60611
United States
Site Number - USA07
Bethesda, Maryland, 20817
United States
Site Number - USA15
Rochester, Minnesota, 55905
United States
Site Number - USA10
Livingston, New Jersey, 07039
United States
Site Number - USA36
Morristown, New Jersey, 07961
United States
Site Number - USA32
New York, New York, 10016
United States
Site Number - USA14
Cincinnati, Ohio, 45229
United States
Site Number - USA39
Cleveland, Ohio, 44195
United States
Site Number - USA35
Columbus, Ohio, 43205
United States
Site Number - USA33
Portland, Oregon, 97239
United States
Site Number - USA22
Charleston, South Carolina, 29425
United States
Site Number - USA34
Memphis, Tennessee, 38103
United States
Site Number - USA31
Fort Worth, Texas, 76104
United States
Site Number - USA25
Houston, Texas, 77030
United States
Site Number - USA03
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Longboard Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-12
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-02-12
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Developmental and Epileptic Encephalopathy
  • LP352
  • Bexicaserin
  • Seizures
  • DEEp OLE
  • Antiseizure medications
  • Epilepsy
  • Neurodevelopmental disorders
  • Dravet syndrome
  • Lennox-gastaut syndrome

Additional Relevant MeSH Terms

  • Developmental and Epileptic Encephalopathy