RECRUITING

A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults with Dravet Syndrome (DS)

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Conditions

Dravet SyndromeAntiseizure medicationEpilepsyNeurodevelopmental disordersDevelopmental and epileptic encephalopathyLP352SeizuresDEEp SEABexicaserin

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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 SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults with Dravet Syndrome

Quick Facts

Study Start:2024-10-02
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06660394

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of DS must fulfill all of the following criteria:
  2. 1. Participants with seizure onset age \>1 and \<20 months
  3. 2. The participant has a history of at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus
  4. * The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic
  5. * The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening.
  6. * The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.
  7. * 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.
  8. * The participant must be willing and able to provide written informed consent.
  1. * The participant has a history of infantile/epileptic spasms.
  2. * The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.
  3. * The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.
  4. * The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.
  5. * The participant is receiving exclusionary medications.
  6. * The participant has used any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).
  7. * 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.
  8. * The participant is unwilling to comply with any of the study requirements or timelines.

Contacts and Locations

Study Contact

Longboard Study Contact
CONTACT
858-999-8858
clinicalstudies@longboardpharma.com

Study Locations (Sites)

Site Number - USA02
Gulf Breeze, Florida, 32561
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 - USA07
Bethesda, Maryland, 20817
United States
Site Number - USA10
Livingston, New Jersey, 07039
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 Date2024-10-02
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-10-02
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Antiseizure medication
  • Epilepsy
  • Neurodevelopmental disorders
  • Developmental and epileptic encephalopathy
  • LP352
  • Seizures
  • DEEp SEA
  • Bexicaserin

Additional Relevant MeSH Terms

  • Dravet Syndrome