A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Purpose
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.
Condition
- Dravet Syndrome
Eligibility
- Eligible Ages
- Between 2 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental LP352 |
Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period. |
|
|
Placebo Comparator Placebo |
Placebo for LP352 |
|
Recruiting Locations
Arkansas Children's Hospital - PIN
Little Rock, Arkansas 72202-3500
Little Rock, Arkansas 72202-3500
David Geffen School of Medicine at UCLA
Los Angeles, California 90095-8346
Los Angeles, California 90095-8346
The Stanford Division of Child Neurology
Palo Alto, California 94304-1510
Palo Alto, California 94304-1510
Children's Hospital Colorado.
Aurora, Colorado 80045-7106
Aurora, Colorado 80045-7106
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida 32561-4458
Gulf Breeze, Florida 32561-4458
Nicklaus Children's Hospital - PIN
Miami, Florida 33155-3009
Miami, Florida 33155-3009
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida 33609-4190
Tampa, Florida 33609-4190
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
Chicago, Illinois 60611
Chicago, Illinois 60611
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817-1844
Bethesda, Maryland 20817-1844
Mayo Clinic - PIN
Rochester, Minnesota 55905-0001
Rochester, Minnesota 55905-0001
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey 07039-5817
Livingston, New Jersey 07039-5817
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
Morristown, New Jersey 07960
Morristown, New Jersey 07960
NYU Comprehensive Epilepsy Center - BRANY - PPDS
New York, New York 10016-4852
New York, New York 10016-4852
Oregon Health and Science University
Portland, Oregon 97239-3011
Portland, Oregon 97239-3011
Le Bonheur Childrens Outpatient Center - PIN
Memphis, Tennessee 38103-2816
Memphis, Tennessee 38103-2816
Child Neurology Consultants of Austin - 6811 Austin Center Blvd
Austin, Texas 78757
Austin, Texas 78757
Cook Children's Jane and John Justin Neurosciences Center - PIN
Fort Worth, Texas 76104-2710
Fort Worth, Texas 76104-2710
The University of Texas Medical School at Houston
Houston, Texas 77030
Houston, Texas 77030
Multicare Health System - Mary Bridge Pediatrics
Tacoma, Washington 98405
Tacoma, Washington 98405
More Details
- Status
- Recruiting
- Sponsor
- Longboard Pharmaceuticals