Developmental and Epileptic Encephalopathy
Conditions
Interventions
-LP352
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube/ nasogastric (NG) tube.
Other Names: Bexicaserin
-Pracebo
Participants will be administered w
Sponsors
Furuzono Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant is >= 6 months to Onset of seizures at 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 ( Does not meet criteria for LGS > Onset of seizures at 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 a minimum of 4 countable motor seizures per month for the 3 months prior to Screening. -The participant has been taking 1 to 4 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
Exclusion criteria: -The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the 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 any cannabis product or cannabidiol within 4 weeks of Screening. -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 (severe hepatic impairment), renal (severe renal impairment), 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Frequency percent change in countable motor seizures during Treatment (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary. | — |
Countries
Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Latvia, Mexico, Netherlands, Portugal, Serbia, Spain, United Kingdom, United States
Contacts
Public ContactHiroshi Furuzono
PPD-SNBL K.K.
Outcome results
None listed