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Purpose

This (DEEp OCEAN 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 DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.

Condition

Eligibility

Eligible Ages
Between 2 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria: - Onset of seizures at ≤8 years old - History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms - Presence of developmental plateauing or regression - History of electroencephalogram (EEG) showing generalized slow (<2.5 Hertz [Hz]) spike-and-wave complexes - Participants who are characterized as having DEE (Other) must fulfill all of the following criteria: - Does not meet criteria for LGS - Onset of seizures at ≤5 years old - Presence of developmental plateauing or regression - History of multiple seizure types - History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity) - 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 each of 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; in instances where the participant is unable to provide consent, an appropriate legal representative.

Exclusion Criteria

  • The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS. - 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 has used of 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 unable or 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

ArmDescriptionAssigned 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.
  • Drug: LP352
    LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube
    Other names:
    • Bexicaserin
Placebo Comparator
Placebo 		Placebo for LP352
  • Drug: Placebo
    Participants will be administered with matching placebo orally or through G-tube/ PEG tube.
    Other names:
    • Placebo Comparator

Recruiting Locations

Massachusetts General Hospital - 175 Cambridge St
Boston 4930956, Massachusetts 6254926 02114

More Details

Status
Recruiting
Sponsor
Longboard Pharmaceuticals

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.