Phase
Condition
Seizure Disorders
Epilepsy
Treatment
Placebo
NPT 2042
Clinical Study ID
Ages 16-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is capable of and provides consent/assent, and the study participant'sparent/legal representative/caregiver provides signed informed consent for minorstudy participants, which includes compliance with the requirements and restrictionslisted in the informed consent form (ICF)
Subject is aged 16-75 years at the time of consent/assent
Subject is diagnosed with genetic generalized epilepsy with absence seizures (consistent with the International League Against Epilepsy (ILAE) Classification ofSeizures (2017))
Subject has electroencephalogram (EEG) evidence of bilateral synchronous generalizedparoxysmal spike-wave (2.5 Hz to 6 Hz) bursts lasting 3 seconds or more at least 4times on the screening 72-hour ambulatory EEG.
Subject has been on a stable dose of at least one antiseizure medication (ASM) forat least 30 days. Vagal nerve stimulation at stable settings (for at least 30 daysbefore screening), without use of the magnet, is also acceptable.
Subject has normal cognition and no clinically significant abnormalities onneurological examination at screening in the opinion of the Investigator
Subject is in otherwise good health (with the exception of epilepsy), as determinedby the investigator, and as documented in the medical history, physical examination,and screening laboratory investigations
Subject has a body mass index (BMI) between 18 and 40 kg/m2 inclusive, at screening
Female subjects of child-bearing potential and all men agree to use of highlyeffective methods of contraception during the study and for 28 days after last doseof study drug
Subject (and parent/caregiver, if applicable) is able to communicate with theinvestigator and to understand and comply with all study requirements, including theclinic visit schedule
Exclusion
Exclusion Criteria:
Subject has metabolic or mitochondrial encephalopathies, seizures associated withstructural abnormalities, or infection-related seizures.
Subject has a developmental epileptic encephalopathy (e.g. Lennox-Gastaut syndrome)
Subject has a history of convulsive status epilepticus within the past year.
Subject has a history of surgical intervention for treatment of epilepsy
Subject has a history of nonepileptic seizures (e.g., metabolic, structural, orparoxysmal non epileptic seizures)
Subject has severe intellectual disability, severe autism spectrum disorder, orsevere developmental disorder such that the subject cannot consent or assent toparticipate or cannot cooperate with the study procedures
Female subject who is pregnant or lactating
Subject has any clinically significant laboratory abnormality which, in the opinionof the investigator, will exclude the subject from the study
Subject has an active CNS infection, demyelinating disease, degenerativeneurological disease, or any CNS disease deemed to be progressive during the courseof the study that may confound the interpretation of the study results
Subject has any clinically significant psychiatric illness, psychological orbehavioral problems which, in the opinion of the investigator, would interfere withthe subject's ability to participate in the study, including but not limited to thefollowing:
Subject has active suicidal ideation prior to study entry as indicated by apositive response ("yes") to either Question 4 or Question 5 of the ColumbiaSuicide Severity Rating Scale (C-SSRS)
Study participant has a lifetime history of suicide attempt (including anactive attempt, interrupted attempt, or aborted attempt)
Subject is suffering from clinically significant active liver disease, porphyria orhas a family history of severe hepatic dysfunction indicated by abnormal liverfunction tests greater than three times the upper limit of normal (AST and ALT)
Subject has a DSM-V diagnosis of alcohol or drug abuse, or drug addiction within thepast 12 months
Subject has participated in any other trials involving an investigational product ordevice within 30 days of screening or longer, as required by local regulations
Subject is currently using prohibited medications or products
Subject is unable to complete ingestion of four placebo SGCs with a minimum of eightounces of water at screening
Subject (and parent/caregiver, if applicable) has daily commitments during the studyduration that would interfere with attending all study visits
Positive urine drug test for substance of abuse or illegal recreational substancesat screening
Study Design
Connect with a study center
Clinical Trials, Inc. (CTI)
Little Rock, Arkansas 77205
United StatesSite Not Available
Clinical Trials, Inc. (CTI)
Little Rock 4119403, Arkansas 4099753 77205
United StatesActive - Recruiting
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