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

What this study is about

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 can join (things the study team will check)

✅ You may be able to join if…

• Diagnosis of DS must fulfill all of the following criteria:
  • Participants with seizure onset age >1 and <20 months
  • 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Arkansas Children's Hospital - PIN, Little Rock, Arkansas, United States
• Children's Hospital Los Angeles - PIN, Los Angeles, California, 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
• Children's National Medical Center, Washington D.C., District of Columbia, 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

+ 89 more sites.

Who to contact

Email contact via H. Lundbeck A/S · +45 36301311 · HQ_Medinfo@Lundbeck.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06660394.