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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of DS must fulfill all of the following criteria: 1. Participants with seizure onset age \>1 and \<20 months 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 - 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 - The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening. - The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening. - 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. - The participant must be willing and able to provide written willing to sign a consent form. Who Should NOT Join This Trial: - The participant has a history of infantile/epileptic spasms. - The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening. - The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing. - The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures. - The participant is receiving exclusionary medications. - The participant is currently using 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosis of DS must fulfill all of the following criteria: 1. Participants with seizure onset age \>1 and \<20 months 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 * 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 * The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening. * The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening. * 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. * The participant must be willing and able to provide written informed consent. Exclusion Criteria: * The participant has a history of infantile/epileptic spasms. * The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening. * The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing. * The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures. * The participant is receiving exclusionary medications. * The participant is currently using 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). * 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. * The participant is unwilling to comply with any of the study requirements or timelines.

Treatments Being Tested

DRUG

LP352

LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube

DRUG

Placebo

Participants will be administered with matching placebo orally or through G-tube/ PEG tube

Locations (20)

Arkansas Children's Hospital - PIN
Little Rock, Arkansas, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
The Stanford Division of Child Neurology
Palo Alto, California, United States
UCSF Children's Hospital
San Francisco, California, United States
Children's Hospital Colorado.
Aurora, Colorado, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
Nicklaus Children's Hospital - PIN
Miami, Florida, United States
Research Institute of Orlando LLC
Orlando, Florida, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
Rare Disease Research, LLC - Atlanta - RDR - PIN
Atlanta, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
Chicago, Illinois, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey, United States
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
Morristown, New Jersey, United States
NYU Comprehensive Epilepsy Center - BRANY - PPDS
New York, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Le Bonheur Childrens Outpatient Center - PIN
Memphis, Tennessee, United States
Child Neurology Consultants of Austin - 6811 Austin Center Blvd
Austin, Texas, United States
Cook Children's Jane and John Justin Neurosciences Center - PIN
Fort Worth, Texas, United States