Actively Recruiting
A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures
Led by NeuroPro Therapeutics, Inc. · Updated on 2025-10-15
10
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic absence seizures, separated by a 14-day washout period. The study will be a single-center, double-blind, crossover study with subjects receiving either NPT 2042 80 mg BID orally or matching placebo BID in each of two treatment periods.
CONDITIONS
Official Title
A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide consent or assent, with parent/legal representative consent for minors
- Aged 16 to 75 years at consent
- Diagnosed with genetic generalized epilepsy with absence seizures per ILAE 2017 criteria
- EEG shows bilateral synchronous generalized paroxysmal spike-wave bursts (2.5-6 Hz) lasting 3+ seconds at least 4 times on 72-hour ambulatory EEG
- On stable dose of at least one antiseizure medication for 30 days or stable vagal nerve stimulation settings for 30 days
- Normal cognition and no significant neurological abnormalities at screening
- In generally good health except for epilepsy, confirmed by medical history and screening tests
- Body mass index between 18 and 40 kg/m2 inclusive at screening
- Females of childbearing potential and all men agree to use effective contraception during the study and 28 days after last dose
- Able to communicate and comply with study requirements including visit schedule
You will not qualify if you...
- Metabolic or mitochondrial encephalopathies, seizures from structural abnormalities or infections
- Developmental epileptic encephalopathy such as Lennox-Gastaut syndrome
- History of convulsive status epilepticus within past year
- History of epilepsy surgery
- History of nonepileptic seizures (metabolic, structural, or paroxysmal non-epileptic)
- Severe intellectual disability, autism, or developmental disorder preventing consent or cooperation
- Pregnant or lactating female
- Clinically significant lab abnormalities excluding participation
- Active CNS infection, demyelinating, degenerative, or progressive neurological disease
- Significant psychiatric illness interfering with participation, including recent suicidal ideation or lifetime suicide attempt
- Active liver disease, porphyria, or family history of severe hepatic dysfunction with abnormal liver tests
- Diagnosis of alcohol or drug abuse/addiction within past 12 months
- Participation in other investigational trials within 30 days or as per local regulations
- Use of prohibited medications or products
- Unable to ingest four placebo softgel capsules with water at screening
- Daily commitments that interfere with study visit attendance
- Positive urine drug test for substance abuse or illegal drugs at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Trials, Inc. (CTI)
Little Rock, Arkansas, United States, 77205
Actively Recruiting
Research Team
J
JoAnn Giannone
CONTACT
C
Charles Moser
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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